• Aim           
• Search and appraisal           
• Introduction           
• Cervical length measurement           
• Definitions:Short cervix. Cervical insufficiency           
• Cervical length and risk of preterm birth:
• Short cervix in a general population 
• Short cervix in a high-risk population
• Management options - General
• Conservative management
• Cervical surveillance
• Progesterone
• Cervical cerclage
• Rest    
• Management options - Population specific:
• General population with an incidental finding of a short cervix
• High-risk population - Asymptomatic
• High-risk population with a short cervix
• Women with multiple gestation 
• Fetal fibronectin test (fFn)
• Location of care
• Post pregnancy loss
• Equivocal evidence or unlikely to be of benefit for practice
• Evidence is lacking and further research is required
• Footnotes
• Additional references
• Appendix 1. Short cervix management options - flowchart
• Appendix 2. Progesterone Research summary
• Appendix 3.  WHA survey responses
• Appendix 4. Evidence tables

Aim

This guideline aims to offer advice to care providers on the assessment and management of women with a diagnosis of cervical shortening and/or cervical insufficiency.

While preterm birth may be the final outcome for a woman with a shortened cervix, management of preterm birth per se is not the focus of this guideline. 3Centres has developed another guideline addressing preterm labour and birth (See http://3centres.com.au/guidelines/preterm-labour/)

Search and appraisal

The following methods of search and appraisal were used: An Ovid platform database selection was made using Medline, Embase, Cochrane databases, for evidence published in English from the year 2000 onwards.

Professional body websites were also used: American College of Obstetricians and Gynecologists (ACOG), Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), Royal College of Obstetricians and Gynaecologists (RCOG), Society of Obstetricians and Gynaecologists of Canada (SOGC).

Other websites accessed: National Health and Medical Research Council (NHMRC), National Institute for Health and Clinical Excellence (NICE) and BMJ Best practice.

Where international guideline groups have cited levels of evidence, these have been referred to in the summary boxes at the conclusion of each section. Also see Appendix 4. Evidence tables.

Search terms used were:  cervical insufficiency, cervical shortening, threatened preterm labour, cervical incompetence, cerclage, tocolytic(s), preterm birth, progesterone, progestational, cervical length

In the compilation of these recommendations, international guidelines and the results of systematic reviews were used to compare facets of care. Contemporary reviews and recommendations from professional bodies were also used. Individual randomized controlled trials were used if they provided a high level of evidence, as determined by the NHMRC evidence level grading criteria.¹

In addition, a survey was circulated to the Women’s Hospitals Australasia (WHA) members to ascertain the routine practice among leading hospital clinicians for the care and management of women with cervical shortening. Seventy surveys were distributed and eleven replies were received, representing a 15.7% response rate. (Appendix 3)

Following an iterative consultation process among key stakeholders from the three tertiary centres, a consensus of opinion was gained in most instances.  In cases of conflicting points of view, a variance process was initiated whereby the Co-Chairs of the 3centres Collaboration made the final decision.

Introduction

One of the challenges facing health care providers is the diagnosis and subsequent management of a woman with a shortened cervix.

While there are many publications relating to the diagnosis and management of women with a shortened cervix, there is a paucity of high level evidence, such as randomised control trials, to support and guide clinical practice. In particular, there are several concerns with the current evidence that contribute to uncertainty about best management strategies. These include:

• There is no uniform definition of a short cervix and cervical length varies with gestation.
• Women are often not stratified into high risk or low risk/no previous risk factors.
• While there is an association between a shortened cervix and preterm labour and birth, most women with a short cervix do not experience a preterm birth and most preterm births are not related to a cervical problem.

It is hoped that this guideline will assist clinicians in the care of women who have been identified as having a short cervix, whether or not they have a prior history of preterm birth or pregnancy loss, thus reducing variation in clinical practice and improving pregnancy outcomes.

It is further anticipated that the guideline will highlight the considerable uncertainties that remain in the provision of care for women with a short cervix. 

The 3centres Collaboration encourages further research to better understand cervical shortening and predict pregnancy outcomes, with a view to developing improved aetiology-directed interventions.

Cervical length measurement

Measurement of cervical length by transvaginal ultrasound (TVU) is considered safe in pregnancy and has been shown to be well tolerated by women.²

The Australian Society of Ultrasound in Medicine (ASUM) recommends that all women having a mid-trimester ultrasound scan should have their cervical length measured.³  ASUM does not provide the evidence to support this recommendation. Indeed, there is no evidence that routine cervical length measurement in all women improves pregnancy outcomes.⁴ Nonetheless, clinicians should be aware that as cervical lengths are increasingly being reported, it is more likely that they will be required to interpret cervical length measurements.

Cervical length changes throughout pregnancy, progressively shortening towards term. Thus, average cervical length is dependant upon the gestation at which it is measured.

Over the past decade or so there have been numerous studies reporting cervical length at varying gestations, in differing populations. The majority of published data relate cervical length at 22-25 weeks gestation. At this gestation, the median (50^th centile) cervical length in singleton pregnancies equates to approximately 35mm.⁵ Other threshold values for clinical decision making at 24 weeks gestation correspond to: 30mm = 25^th centile, 25mm = 10^th centile, 20mm = 5^th centile.

In Australia the majority of women have their mid-trimester ultrasound examination performed at 18-20 weeks gestation. There are no published population data on cervical length at this gestation.

Cervical length is most accurately measured by transvaginal ultrasound and only after the woman has emptied her bladder. The cervix is measured with the ultrasound probe directed into the anterior fornix of the vagina. Pressure on the cervix may artificially increase the length and should be avoided. The cervix is measured in the saggital view from the internal os to the external os. The measurement may be taken in a straight line or a curved line. The cervix should be assessed over several minutes and the shortest measurement reported.⁶ Cervical length measured in this manner is highly reproducible.

In addition to measuring length, some authors have described the use of provocation tests to induce funnelling, such as fundal pressure, coughing, standing or Valsalva manoeuvre during assessment of the cervical length. There is no evidence that such tests improve the utility of cervical length as a predictor of pregnancy outcome when compared to cervical measurement without provocation.  In the absence of such evidence, cervical provocation tests cannot be recommended for clinical practice.⁷

A variety of terms have been used to describe the cervix further, such as “funnelling”, “beaking” or “wedging”. These terms have been used with no clear definition, or distinction between them when during ultrasound, there is the invagination of the membranes and amniotic fluid into the proximal end of the endocervical canal. This invagination will continue as the cervix shortens and dilates. If the membranes remain intact there may be a large portion ballooning out into the vagina, known as “hourglass membranes”. The presence of funnelling with a shortened cervix is considered an ominous sign, associated with an increased risk of preterm birth.⁸

Definitions

Short cervix

Recognising the association between cervical shortening and risk of spontaneous preterm birth, the discovery of a short cervix may change the care offered to an individual woman.

However, there are no uniform criteria defining a “short cervix”, and the inverse relationship between cervical length and risk of preterm birth is likely to be a continuum. The most frequently used definition of a shortened cervix is one that measures less than 25mm (10^th centile) on a TVU scan at 20–24 weeks gestation. By definition, approximately 8-10% of women will have a cervical length of <25mm at 23 weeks gestation.⁹

There is no evidence that targeting interventions by a cervical length of <25mm is associated with improved pregnancy outcomes. However, there is recent evidence that using a cervical length of <20mm (5^th centile) in both population groups of women (no previous risk factors with a short cervix and those at high-risk of a preterm birth with a short cervix) may allow directed care that improves pregnancy outcomes.¹⁰

For this reason 3Centres recommend using a cervical length ≤20mm at 18-22 weeks gestation to define a threshold where specific care may then be considered.

In addition to cervical length per se, clinicians are encouraged to consider other factors that may put the woman at high risk for spontaneous preterm birth such as the number of fetuses, the presence of infection, previous obstetric history, the presence or absence of symptoms, rate of change of cervical length and gestational age at which the cervical length was obtained. (The earlier in gestation the shortening is detected, the higher the risk of preterm birth)

Cervical insufficiency

Cervical insufficiency is thought to be due to a congenital or acquired (e.g. by previous surgery) structural weakness of the cervix.

The term “cervical incompetence” is considered pejorative and insensitive. It is recommended that this term is no longer used.

Typically, women with cervical insufficiency present with painless, cervical shortening and dilatation in mid-pregnancy, which is sometimes associated with an increased, watery vaginal discharge, and/or increasing pressure symptoms.

Cervical insufficiency is associated with an increased risk of mid-trimester pregnancy loss or preterm birth and this guideline also aims to direct future care for those women with a past diagnosis of cervical insufficiency that has led to a pregnancy loss.

Cervical length and risk of preterm birth

There is a strong inverse relationship between cervical length in mid-pregnancy and the risk of preterm birth. Measurement of cervical length provides an accurate prediction of that risk. This relationship is particularly enhanced in women at high risk of preterm birth, such as those with a previous pregnancy loss or cervical surgery. In essence, the shorter the cervix, the earlier the gestation, the higher the risk of preterm birth, a risk that is exacerbated if other risk factors are present.⁵

For example, in a large (nearly 40,000 women) population-based prospective multicentre study:
1% of women had a cervix <15mm and 35% of these women gave birth before 32 weeks; 20% of women had a cervix 16-25mm and 10% of the women gave birth before 32 weeks.¹¹ 

Similarly, in another large study, 2% of women had a cervical length ≤ 15 mm at 23 weeks; these women accounted for 90% and 60% of the women experiencing a preterm birth at ≤ 28 and ≤ 32 weeks, respectively.⁹

If a shortened cervix is observed on ultrasound scan at 18-22 weeks gestation, women should be able to have an extensive discussion about the risks of preterm birth with a senior obstetrician and/or a neonatologist. Written information should also be provided.

Short cervix in a general, low-risk population

In a low-risk population without recognised risk factors, the incidence of preterm birth before 35 weeks gestation when cervical length was <25mm measured at 24 weeks gestation, has been reported in one paper as 3% in a population of 2107 women studied.¹²

Short cervix in a high-risk population

In addition to cervical length, an individual woman’s medical and pregnancy history and ethnic origin may also identify her at high risk of spontaneous preterm birth. 

The following table, derived from a population of high-risk women, is a further illustration of the predictive value of cervical length and the risk of preterm birth. It may be useful when discussing on-going management options with women. 

 Table 1. Predicted probability of preterm delivery before week 28, by cervical length (mm) and time of measurement (week of pregnancy) in a high-risk population. Adapted from: Berghella et al 2007.¹³

Management options - General

Conservative management

In the absence of specific evidence, in certain circumstances clinicians in consultation with the woman, may reasonably choose conservative management as the initial preferred option. See population specific options.

Cervical surveillance

As above and due to the heterogeneity of many research studies, cervical surveillance by transvaginal ultrasound serial scans, may be the option of choice. See population specific options.

Progesterone

In recent years there has been renewed interest in the use of prophylactic progesterone in women at high-risk of preterm birth. A number of randomized clinical trials have been completed that address different populations of women however, the optimal dose, route of administration, and gestational age at which to commence and cease progesterone therapy, remains inconclusive at present. A number of other clinical trials are on-going that may assist in informing future practice. See population specific options for 3centres recommendations.

Cervical cerclage

There have been various terms used to describe cervical cerclage sutures such as prophylactic, therapeutic or emergency. These terms are now considered ambiguous and therefore for the purpose of this guideline, we have used the definitions of cervical sutures as suggested by the Royal college of Obstetricians and Gynaecologists in May 2011 as follows:¹⁴

History-indicated cerclage
Insertion of a cerclage as a result of factors in a woman’s obstetric or gynaecological history, which increases the risk of spontaneous second-trimester loss or preterm delivery. A history-indicated suture is performed as a prophylactic measure in an asymptomatic woman and normally inserted electively at 12–14 weeks of gestation.

Ultrasound-indicated cerclage
Insertion of a cerclage as a therapeutic measure in cases of cervical length shortening seen on transvaginal ultrasound. Ultrasound-indicated cerclage is performed on asymptomatic women who do not have exposed fetal membranes in the vagina. Sonographic assessment of the cervix is usually performed between 14 and 24 weeks of gestation.

Rescue cerclage
Insertion of cerclage as a salvage measure in the case of premature cervical dilatation with exposed fetal membranes in the vagina. This may be discovered by ultrasound examination of the cervix or as a result of a speculum/physical examination performed for symptoms such as vaginal discharge, bleeding or ‘sensation of pressure’. 

The decision to place a rescue cerclage should be individualised and is dependant upon the gestation at presentation. 3centres recommends caution when considering inserting a rescue cerclage at later gestations as there is insufficient evidence to recommend this practice. A senior obstetrician should be involved in this decision making.

Cerclage type
There are two types of transvaginal cerclage, Shirodkar and McDonald. The Shirodkar technique involves reflecting vaginal skin allowing placement of the suture high up around the cervix, as close as possible to the level of the internal cervical os. The McDonald ‘purse string’ technique involves inserting the suture around the intravaginal portion of the cervix, without reflection of vaginal skin, and is technically simpler to perform. Currently, there is no evidence to recommend one type of suture over the other.

Transabdominal cerclage, either by laparoscopy or laparotomy, is an option if a previous transvaginal cervical cerclage has failed or it is not technically possible. Laparoscopic placement of a cerclage can be performed in pre-pregnancy or in early pregnancy. Both transabdominal cerclage options require a general anaesthetic. The fetus is later delivered by caesarean section. 

Clinicians should decide which technique to use, based on their experience and expertise, and on the woman’s history.

Cervical cerclage may be placed under a regional or general anaesthetic.

Cerclage complications
Recognised complications of cervical cerclage include bleeding from suture placement, infection, preterm prelabour rupture of membranes (PPROM). Suture displacement secondary to uterine contractions may also occur, owing to the presence of a foreign body. Also, with the use of a general anaesthetic for any procedure, there are potential anaesthetic risks to consider.

There is insufficient evidence to guide practice when a woman has preterm pre-labour rupture of membranes (PPROM) and a cervical cerclage in situ. The results from an on-going multi-centre trial will help to guide future practice.¹⁵ Until the results from that trial have been published, most common clinical practice is to remove a cervical suture if a woman presents with PPROM.

Transvaginal cerclage should be removed in late pregnancy to allow a normal vaginal birth. There is limited evidence to guide the timing of removal but it is most common to remove a suture at or after 37 weeks gestation. Women should be counselled that there is about a 10% chance of spontaneous labour in the 48 hours following cerclage removal. Routine induction of labour at the time of cerclage removal cannot be recommended. The suture should be removed at any gestation in the presence of established labour or chorioamnionitis.¹⁵

The role of perioperative antibiotics associated with cerclage placement.
The use of unnecessary antibiotics may lead to the development of resistant strains of bacteria.
This has implications for other morbidity for the woman and her fetus. Therefore, the use of prophylactic antibiotic therapy is not recommended.

The role of Indomethecin/tocolytics following cerclage placement
In two studies, the use of indomethecin following ultrasound indicated placement of cerclage, did not demonstrate a reduction in preterm birth when compared to those receiving cerclage alone. The routine use of Indomethecin is not recommended until future research can guide practice.^16,17 There have been no randomized studies to show that the routine use of any tocolytic therapy after cerclage placement is effective. Therefore, routine tocolytic therapy following cerlage placement cannot be recommended.

Rest

Hospitalisation and bed-rest have been the past recommendations by many clinicians. However, there is no evidence that bedrest improves pregnancy outcomes in women who have a finding of a short cervix. Bed rest and/or hospitalization is not recommended for any population group unless very individual circumstances dictate it so.^18,19

Population specific management options

General population - Low-risk women

It is important to be able to advise and provide appropriate care for low-risk women who have no previously known risk factors and have an incidental finding of a shortened cervix on a routine TVU scan. The number of these women may be increasing due to the widespread use of high quality ultrasound and use of the transvaginal route.

Conservative management:

There is insufficient evidence to recommend routine transvaginal serial ultrasound assessment of cervical length in women with no risk factors. Ultrasound screening lacks the discriminatory power to be used effectively in a low risk population. However, in the case of a routine ultrasound study of the fetal and maternal anatomy, cervical length may often be included in the assessment.

In women with a cervical length of between 20-25mm, there is insufficient evidence to support any specific intervention. These women should be advised that their risk of spontaneous preterm birth is less than 5%. In the absence of evidence, some clinicians may choose to repeat TVU length measurement 1-2 weeks later.

If an incidental finding of a shortened cervix is diagnosed but has not reached ≤ 20mm, there is limited evidence available to recommend any other form of management beyond additional surveillance. In this situation, an experienced clinician should review the ultrasound findings and discuss options with the woman, according to her physical and psychosocial circumstances. Routine admission to hospital cannot be recommended, as there is no evidence that hospitalisation or bed-rest reduces the risk of preterm birth in these women.

Progesterone:

There is limited evidence examining the effectiveness of vaginal progesterone solely in a low-risk population of women with an incidental finding of a short cervix.

In one trial that included low and high-risk women, the authors concluded that in women whose cervix was <15mm, by giving 200mg of vaginal progesterone daily from 24 – 34 weeks gestation, their risk of preterm birth reduced by 44% (19% in the placebo group, 34% in the progesterone group). This was not associated with a significant improvement in neonatal outcome.²⁰

A multicentre, randomised, double-blind, placebo controlled trial, in a mixed population (risk stratified-16% had a history of preterm birth), 458 women with a shortened cervix (10-20 mm) at 19 - 24 weeks gestation, were administered 90mg of vaginal progesterone gel. In women without a history of preterm birth (84% of the population), vaginal progesterone administration was associated with a significant reduction (almost 50%) in the rate of preterm birth before 33 weeks, (7.6% vs 15.3%).

Within the whole treatment group, overall there was a 45% reduction in the rate of preterm birth before 33 weeks gestation, and improved neonatal outcomes.¹⁰

3 centres Collaboration recommends offering vaginal progesterone 90mg - 200mg to women who are shown to have a cervix <20mm at 18-22 weeks gestation. On average, this would be expected to halve their risk of preterm birth.

Alternatively, the offer of vaginal progesterone (200mg capsule nocte) is recommended to women who are shown to have a cervix <15mm at 20-25 weeks gestation. On average, this would expect to reduce their risk of preterm birth at <34 weeks by 44% 

Cervical cerclage:

There is no evidence to show that the insertion of an ultrasound indicated cerclage in women in whom the diagnosis of a short cervix is an incidental finding, improves pregnancy outcome. Accordingly, cervical cerclage is not recommended for women who have an incidental finding of a short cervix.²¹

Rest:

 There is no evidence that bedrest improves pregnancy outcomes in women who have the incidental finding of a short cervix. Bed rest and/or hospitalization is not recommended.^18,19,22

High-risk women - Asymptomatic

The risk factors for cervical shortening leading to preterm birth should be evaluated at the first antenatal visit. Because cervical shortening may lead to preterm birth, the risks of preterm birth should be discussed with all high-risk women. The outcome of all discussions needs to be clearly documented.

There is insufficient evidence on which to base strong recommendations for the management of women at high risk of cervical shortening and preterm birth. In discussion with the woman, clinicians may choose from three broad approaches to management, singularly or in combination. Care for each woman is individualised, dependent upon her gestation, history and circumstances, and on the considerations of an experienced clinician. 

Cervical surveillance:

If cervical length surveillance is the preferred management option for high-risk women, then serial TVU scans should be offered, starting at about 16 weeks gestation, or earlier if indicated by the woman’s history and risk factors.²⁵ It may also be appropriate that the frequency of antenatal visits is increased to allow timely review of the ultrasound results.

There is no agreed optimum frequency of cervical scanning. In general, it is recommended that cervical ultrasounds should be performed from weekly to every four weeks. However, the frequency of ultrasound scanning is dictated by the gestation, cervical length, and rate of change, pre-existing risk factors or if there is a change in the clinical picture. A woman with changing symptomatology, increasing pelvic pressure or mucoid discharge, may require more frequent scans. The benefit of cervical surveillance is that it is a non-invasive option.

If changes are observed on ultrasound surveillance then the next step(s) in management should be discussed with the woman.

Progesterone:

Systematic reviews from a number of randomised trials have shown that progesterone reduces the risk of preterm birth in high-risk women, who have had a previous, spontaneous preterm birth.^26,27

In the population of women at high risk for preterm birth who currently have a normal cervical length, two trials of significance demonstrated that the use of prophylactic progesterone reduced their incidence of preterm labour and birth. 

In the first trial, a daily dose of 100mg of vaginal progesterone in women with a history of preterm birth, administered between 24–34 weeks gestation, showed that progesterone administration was associated with delayed cervical shortening as pregnancy progressed, a lower rate of preterm birth, a lower frequency of newborn admission to the intensive care unit and a shorter length of neonatal stay.²⁸

More recently, a secondary analysis of one randomized controlled trial suggested that the use of progesterone is more effective in prolonging pregnancy of women with a history of spontaneous preterm birth <34 weeks gestation. Women were given progesterone (17-alpha hydroxyprogesterone caproate) from 15-20⁺⁴ weeks gestation until 36 weeks gestation.²⁹  17-alpha hydroxyprogesterone caproate is not currently available for use in Australia.

If it is decided that vaginal progesterone is indicated, then until further evidence is available to guide otherwise, 3Centres recommends the use of 90-200mg vaginal progesterone suppository daily until 34 weeks gestation.

Cervical cerclage:

Recent data suggest that using ultrasound to identify women at risk of cervical insufficiency because of a history of preterm birth reduces unnecessary cerclage rates and results in similar pregnancy outcomes as cerclage placement on the basis of history alone.^30,31 Thus, the use of cervical surveillance for identifying cerclage candidates may usefully reduce the number of cerclages inserted.

A history indicated cerclage is inserted in asymptomatic women who are at risk of mid-pregnancy loss and/or very preterm birth based on previous obstetric risk factors (>2 previous PTB) where the attending clinician(s) believe that cervical insufficiency was a major contributor to the loss.¹⁴

The suture is placed prior to any cervical change, typically at 13-16 weeks gestation, once the risk of early miscarriage has passed. Insertion at 14 weeks also allows completion of first trimester aneuploidy testing, if desired, prior to cervical cerclage. 

Rest:

Clinicians often recommend additional rest in the belief that it reduces the gravitational challenge on the cervix, particularly where physical exertion (prolonged standing, long occupational hours, heavy lifting etc) may increase the likelihood of preterm birth. However there is no direct evidence that recommending bed-rest is beneficial for a woman at risk of preterm labour and it should not be recommended.^18,19

High-risk women with a short cervix

This group of high-risk women are found to have a shortened cervix during surveillance.

The management options to be considered and discussed with an individual woman who has been shown to have a shortened cervix will depend on the clinical situation, including other signs or symptoms of labour or chorioamnionitis, the number of fetuses in utero, other high-risk factors, cervical length and gestational age at which the cervical length was obtained. The management options detailed in this guideline relate to the woman with a singleton pregnancy who is not in labour and who does not have chorioamnionitis.

Cervical surveillance:

As per cervical surveillance option above for high-risk women - asymptomatic. However, without some form of intervention, the risk of fetal loss is high in this group of women and therefore it is not likely to be the preferred option.

Progesterone:

In addition to the use of progesterone in a mixed population of high and low risk women, there are two more trials that focused on those high-risk women who presented with a shortened cervix.

The first in 2007 De Franco et al, (as a secondary analysis of the O’Brien et al trial in 2007), concluded that women at high-risk for a preterm birth who had a short cervix, should be offered progesterone 90mg daily if their cervix measured <28mm.³²

The O’Brien et al trial in 2009 reported that by offering high-risk women whose cervix was <25mm 90mg of progesterone daily, this will significantly preserve the cervical length.³³

The optimum dose and timing of progesterone remains to be determined. Until further evidence is available to better guide practice, 3Centres recommends the use of 90mg-200mg progesterone daily, or 200mg nocte until 36 weeks gestation.

Cervical cerclage:

A trial of ultrasound indicated cerclage in women with a history of preterm loss between 17 and 37 weeks gestation and cervical length <25mm detected at 16-22 weeks gestation, concluded that cerclage prevented preterm birth when compared to expectant management at <24 weeks gestation 6.1% versus 14%; P = 0.03) and perinatal death (8.8% versus 16%; P = 0.046) but did not prevent birth at less than 35 weeks of gestation (32% versus 42%; OR = 0.67; 95% CI 0.42–1.07) unless cervical length was less than 15 mm (OR 0.23; 95% CI 0.08–0.66)³⁴

Further, the results from a meta analysis of four RCT’s reviewing cerclage, showed that the intervention seemed to have a similar effect regardless of the degree of cervical shortening, including cervical lengths of 16–24 mm, as well as cervical lengths of 15.9mm.³⁵

If cerclage is the preferred management option in a woman who has had one or more mid-trimester losses, 3centres recommend that it be placed at <25 weeks gestation and only if the cervix has reached ≤25mm.

Rest:

There is no direct evidence that recommending bed-rest is beneficial for a woman at risk of preterm labour and it should not be recommended.^18,19

Women with multiple gestation

While women with a multiple pregnancy are considered high-risk for preterm labour and birth, there is insufficient evidence to support the recommendations for cervical cerclage as per the previous categories.^18,20,36 

Similarly, there is insufficient evidence to recommend the use of progesterone for women with multiple gestations.^37,38

Fetal fibronectin test (fFN)

Occasionally a woman may present with a shortened cervix who is contracting. The treating clinician needs to ascertain whether this is an incidental finding of a shortened cervix or a short cervix that has effaced as part of preterm labour and if risk factors are present.

A negative fFn test has a very high negative predictive value: 99% of women with a negative result will not proceed to give birth in the following 7 days.

In one study in a high-risk pregnancy, the use of cervical length measurements in combination with fFN testing regardless of risk factors, concluded that a short cervix predicted a subsequent positive fetal fibronectin result, and a positive fetal fibronectin result predicted subsequent cervical shortening.³⁹Therefore the use of fFN test in the presence of a short cervix might assist with further management.

Factors that may affect the fFN test results: Any cervical manipulation within the previous 24 hours, such as coitus, digital vaginal examination and TVU examination may affect the result. However, this should not dissuade the clinician from performing the test, even in the face of a positive result due 

to extraneous factors. Fetal fibronectin is also found in blood and semen, and these may cause false positive results however, negative results in any of these settings can still be considered reliable.

Dependant upon her gestation, if the woman is not already in a level 6 (tertiary) care setting, is symptomatic with a positive fFN result, it is advisable that the clinician consult with the Perinatal Emergency Services (PERS) for further assistance. (See below- Location of care)

Table 3. Fetal fibronectin test

Location of care

The location of care will be dependent upon risk factors, gestation, planned management and the hospital facilities. At the extremes of gestation (less than 23 weeks and greater than 32-37 weeks), in consultation with specialists at a level 6 (tertiary) hospital, it may be suggested that the on-going management of women with a shortened cervix could be provided from a local secondary hospital.

Women who present with a shortened cervix between 23-32 weeks gestation, may be managed in consultation with clinicians at a Level 6 (tertiary level) hospital.

When management has been instituted and the woman is clinically stable, ongoing management as an outpatient can be considered.  If outpatient management is offered, women should be provided with clear follow-up arrangements and twenty-four hour access to obstetric services.  

Post pregnancy loss

All women who have had a second or third trimester pregnancy loss or preterm delivery due to cervical shortening should be offered a follow up postnatal consultation with a senior obstetrician. This would usually be organised for about six weeks postpartum. Discussion about the management of future pregnancies is important.

Information regarding the pregnancy, cause of cervical shortening and delivery should be provided to the general practitioner, as well as a plan for future pregnancies.

Equivocal evidence or unlikely to be of benefit for practice

Evidence is lacking and further research is required

Footnotes

1. NHMRC  Levels of evidence and grades for recommendations for developers of guidelines. December 2009. Available from: www.nhmrc.gov.au/_files_nhmrc/file/guidelines/evidence_statement_form.pdf
2. Dutta R, Ultrasound in Obstetrics & Gynecology: The official Journal Of The International Society Of Ultrasound in Obstetrics And Gynecology (Blackwell) Volume: 22 Issue 5 (2003-01_01) p.503-507. ISSN:0960_7692
3. Australasian Society for Ultrasound in Medicine, polices and statements - guidelines for the mid trimester obstetric scan. Available from: http://www.asum.com.au/site/files/P&S/D2_policy.pdf
4. Berghella V, Baxter JK, Hendrix NW. Cervical assessment by ultrasound for preventing preterm delivery. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD007235. DOI: 10.1002/14651858.CD007235.pub2.
5. Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, and Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. The New England Journal Of Medicine, 334(9):567–572, 02 1996.
6. Fetal Medicine Foundation. Available from: https://courses.fetalmedicine.com/fmf/introduction.
7. RANZCOG. Measurement of cervical length in pregnancy for prediction of preterm birth. Available from: www.ranzcog.com.au
8. Angtuaco TL et al, Expert Panel on Women's Imaging. ACR Appropriateness Criteria® assessment of gravid cervix. American College of Radiology (ACR); 2008. 5p
9. Heath VC, Southall TR, Souka AP, et al: Cervical length at 23 weeks of gestation: prediction of spontaneous preterm delivery. Ultrasound Obstet Gynecol 12:312-317, 1998.
10. Hassan S, et al, 2011;Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial ;Ultrasound in Obstetrics & Gynecology (in press) DOI: 10.1002/uog.9017.
11. To MS, Skentou CA, Royston P, et al: Prediction of patient-specific risk of early preterm delivery using maternal history and sonographic measurement of cervical length: a population-based prospective study. Ultrasound Obstet Gynecol 27:362-367, 2006.
12. Iams JD, Goldenberg RL, Mercer BM, Moawad AH, Meis PJ, Das AF, Caritis SN, Miodovnik M, Menard MK, Thurnau GR, Dombrowski MP, and Roberts JH. The preterm prediction study: can low-risk women destined for spontaneous preterm birth be identified? American Journal Of Obstetrics And Gynecology, 184(4):652–655, 03 2001.
13. Berghella V, Roman A, Daskalakis C, Ness A, and Baxter JK. Gestational age at cervical length measurement and incidence of preterm birth. Obstetrics And Gynecology, 110(2 Pt 1):311–317, 08 2007. 
14. Shennan AH, To MS: RCOG Green Top Guidelines: Cervical cerclage RCOG. 2011. Available from: www.rcog.org.uk
15. Removal-v-retention of cerclage in preterm, pre-labor rupture of membranes. ClinicalTrials.gov identifier: NCT00201656
16. Berghella, V. Prasertcharoensuk, W. Cotter, A. Rasanen, J. Mittal, S. Chaithongwongwatthana, S Gomez, R. Kearney, E.. Tolosa, J.E. and Pereira, L. Does indomethacin prevent preterm birth in women with cervical dilatation in the second trimester? American Journal Of Perinatology, 26(1):13–19, 01 2009.
17. Visintine, J. Airoldi, J and Berghella, V. Indomethacin administration at the time of ultrasound- indicated cerclage: is there an association with a reduction in spontaneous preterm birth? American Journal Of Obstetrics And Gynecology, 198(6), 06 2008.
18. Goldenberg RL, Cliver SP, Bronstein J, et al. Bed rest in pregnancy. Obstet Gynecol. 1994;84:131–136.
19. Sosa, C. Althabe, F. Belizan, J and Bergel, E. Bed rest in singleton pregnancies for preventing preterm birth. Cochrane database of systematic reviews (Online), (1), 2004. 
20. Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 2007; 462-469.
21. Berghella V, Odibo AO, To MS, Rust OA, Althuisius SM. Cerclage for short cervix on ultrasonography: meta-analysis of trials using individual patient-level data. Obstet Gynecol 2005; 106(1):181-9.
22. Fox NS Does hospitalization prevent preterm delivery in the patient with a short cervix Am J Perinat 2007; 24: 49-53
23. Visintine, J Berghella, V Henning, Dand Baxter, J. Cervical length for prediction of preterm birth in women with multiple prior induced abortions. Ultrasound in Obstetrics & Gynecology, 31(2):198–200, 2008.
24. Goldenberg RL, Culhane JF, Iams JD, and Romero R. Epidemiology and causes of preterm birth. The Lancet, 371(9606):75–84, 1 2008.
25. ACOG Practice bulletin No. 48 Cervical Insufficiency. Obstetrics and Gynecology, Volume 102, No. 5, November 2003, pp. 1091-1099(9)
26. Dodd JM, Flenady VJ, Cincotta R, Crowther CA. Progesterone for the prevention of preterm birth. Obstet Gynecol 2008; 112: 127-134.
27. Sanchez-Ramos, L Kaunitz, AM and Delke, I. Progestational agents to prevent preterm birth: a meta-analysis of randomized controlled trials. Obstetrics And Gynecology, 105(2):273–279, 02 2005.
28. da Fonseca EB, et al.Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk:a randomized placebo-controlled double-blind study.American Journal of Obstetrics & Gynecology 2003;188(2):419–24.
29. Spong CY, Meis PJ, Thom EA, Sibai B, Dombrowski MP, Moawad AH, Hauth JC et al. Progesterone for prevention of recurrent preterm birth: Impact of gestational age at previous delivery. Am J Obstet Gynecol 2005; 193: 1127–1131.
30. Blikman M. et al, Ultrasound-Predicated Versus History-Predicated Cerclage in Women at Risk of Cervical Insufficiency A Systematic Review, Obstetrical & Gynecological Survey: December 2008 - Volume 63 - Issue 12 - pp 803-812
31. Higgins SP, Kornman LH, Bell RJ, et al. Cervical surveillance as an alternative to elective cervical cerclage for pregnancy management of suspected cervical incompetence. Aust N Z J Obstet Gynaecol 2004;44:228–232.
32. DeFranco EA, O'Brien JM, et al, Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct; 30(5):697-705.
    
33. O’Brien JM, DeFranco EA, Adair CD, et al. effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, doubleblind, placebo-controlled trial. Ultrasound Obstet Gynecol 2009;34:653-9.
34. Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, et al. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol 2009;201:375.e1–8.
35. Berghella V, Keeler SM, To MS, Althuisius SM, and Rust OA. Effectiveness of cerclage according to severity of cervical length shortening: a meta-analysis. Ultrasound In Obstetrics & Gynecology: The Official Journal Of The International Society Of Ultrasound In Obstetrics And Gynecology, 35(4):468– 473, 04 2010.
36. Jorgensen A, Alfirevic Z, Tudur Smith C, Williamson P; on behalf of the cerclage IPD Meta-analysis Group. Cervical stitch (cerclage) for preventing pregnancy loss: individual patient data meta-analysis. BJOG 2007;114:1460–1476.
37. Dodd J, Flenady V, Cincotta R, Crowther C. Prenatal administration of progesterone for preventing preterm birth (review). The Cochrane Database Syst Rev 2006. CD004947.
38. Norman JE et al. Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomized, double-blind, placebo-controlled study and meta-analysis. Lancet. 2009;373:2034–40.
    
39. Goldenberg RL, Iams DJ, Das A, Mercer BM, Meis PJ, Moawad AH, Miodovnik M, VanDorsten JP, Caritis SN, Thurnau GR, Dombrowski MP, Roberts JM, and McNellis D. The preterm prediction study: sequential cervical length and fetal fibronectin testing for the prediction of spontaneous preterm birth. national institute of child health and human development maternal-fetal medicine units network. American Journal Of Obstetrics And Gynecology, 182(3):636–643, 03 2000.
    

Additional references

• Berghella V. Novel developments on cervical length screening and progesterone for preventing preterm birth. BJOG 2009;116:182–187.
• Berghella V Ultrasound assessment of the cervix Clin.Obstet Gynecol. 2003; 46: 947-62
• BMJ-Best Practice. Prophylactic cervical cerclage in women at risk of preterm labour with protruding membranes. Available from: http://bestpractice.bmj.com/best-practice/evidence/intervention/1404/1/sr-1404-i15.html. Accessed December 2009.
• Bisulli, M et al. Interval to spontaneous delivery after elective removal of cerclage. Am J Obstet Gynecol 201(2):163.e1-4 (2009)
• BMJ-Best practice. Prophylactic cervical cerclage in women at risk of preterm labour with cervical changes. Available from: http://bestpractice.bmj.com/best-practice/welcome.html. Accessed December 2009.
• BMJ-Best practice. Preterm birth available from:http://bestpractice.bmj.com/best-practice/evidence/1404.html. Accessed December 2009.
• BMJ-Best Practice. Antibiotic treatment for preterm labour with intact membranes. Available from : http://bestpractice.bmj.com/best-practice/evidence/intervention /1404/0/sr-1404-i8.html. Accessed December 2009.
• Cincotta R, Gardner D, Duncombe G, Flenady V. J.D. Antenatal administration of progesterone for preventing preterm birth (protocol). The Cochrane Database Syst Rev 2004. CD004947.
• Daskalakis DJ, Prematurity prevention: the role of cerclage. Curr Opin Obstet Gynecol 21:148–152.
• Hoesli I, M.Strutas D.; Tercanli S.; Holzgreve W. Charts for cervical length in singleton pregnancy International Journal of Gynecology and Obstetrics, Volume 82, Number 2, August 2003 , pp. 161-165(5).
• Honest H, Bachmann LM, Coomarasamy A, Gupta JK, Kleijnen J, Khan KS. Accuracy of cervical transvaginal sonography in predicting preterm birth: a systematic review. Ultrasound Obstet Gynecol 2003; 22(3):305-22.
• Jenkins SM Dynamic cervical change: is real-time sonographic cervical shortening predictive of preterm delivery in patients with symptoms of preterm labor? Ultrasound Obstet Gynecol 2006; 27: 373-6.
• Odibo AO, Berghella V, To MS, Rust OA, Althuisius SM, Nicolaides KH. Shirodkar versus McDonald cerclage for the prevention of preterm birth in women with short cervical length. Am J Perinatol. 2007 Jan;24(1):55-60. Epub 2006 Dec 27.
• Pramod R, Okun N, McKay D, Kiehn L, Hewson S, Ross S, Hannah ME. Cerclage for the short cervix demonstrated by transvaginal ultrasound: current practice and opinion. J Obstet Gynaecol Can. 2004. Jun;26(6):564-70.
• RANZCOG College position statement. Measurement of cervical length in pregnancy for prediction of preterm birth. November 2008. Available from:www.ranzcog.edu.au/publications/collegestatements.shtml. Accessed November 2009.
• Rode L, Langhoff-Roos J, Andersson C, Dinesen J, Hammerum M.S, Mohapeloa H , Tabor A. Systematic review of progesterone for the prevention of preterm birth in singleton pregnancies. Acta Obstetricia Et Gynecologica Scandinavica, 88(11):1180–1189, 2009.
• Smith V; Devane D; Begley CM; Clarke M; Higgins S. A systematic review and quality assessment of systematic reviews of randomized trials of interventions for preventing and treating preterm birth. European Journal Of Obstetrics, Gynecology, And Reproductive Biology [Eur J Obstet Gynecol Reprod Biol] 2009 Jan; Vol. 142 (1), pp. 3-11.
• Kenyon S, Boulvain M, Neilson J. Antibiotics for preterm rupture of membranes. The Cochrane Database Syst Rev 2003. CD001058.
• King J, Flenady V, Cole S, Thorton S. Cyclo-oxygenase (COX) inhibitors for treating preterm labour. The Cochrane Database Syst Rev 2005. CD001992.
• National Institute for Health and Clinical Excellence (NICE). Interventional procedure overview of laparoscopic cerclage for prevention of recurrent pregnancy loss due to cervical incompetence. August 2007. Available from: http://guidance.nice.org.uk/IPG228. Accessed November 2009.
• SOGC. Ultrasound cervical assessment in predicting preterm birth. No. 102, May 2001.
• Available: http://www.sogc.org/guidelines/public/102E-CPG-May2001.pdf.
• SOGC.  The use of progesterone for prevention of preterm birth. No. 202, January 2008, J Obstet Gynaecol Can 2008;30(1):67–71. Available: http://www.sogc.org/guidelines/documents/guiJOGC202TU0801.pdf.

Appendix 1. Short cervix management options - Flowchart

 Short cervix Flowchart (Opens in a new window)

Appendix 2. Progesterone research summary

Progesterone research summary (Opens in a new window)

Appendix 3. WHA survey responses

WHA survey page 1. (Opens in a new window)
WHA survey page 2. (Opens in a new window)

Appendix 4. Evidence tables

NHMRC Evidence table (Opens in a new window)

American College of Obstetricians and Gynecologists (ACOG)

Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories:
Level A - Recommendations are based on good and consistent scientific evidence.
Level B - Recommendations are based on limited or inconsistent scientific evidence.
Level C - Recommendations are based primarily on consensus

Royal College of Obstetricians and Gynaecologists (RCOG)

RCOG evidence grades
A Requires at least one randomised controlled trial as part of the body of literature of overall good quality and consistency addressing the specific recommendation.
B Requires availability of well-conducted clinical studies but no randomised clinical trials on the topic of recommendation.
C Requires evidence from expert committee reports or opinions and/or clinical experience of respected authorities. Indicates absence of directly applicable studies of good quality.
Good practice point. Recommended best practice based on the clinical experience of the guideline development group.

The Society of Obstetricians and Gynaecologists of Canada (SOGC)

Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force on Preventive Health Care
I: Evidence obtained from at least one properly randomized controlled trial
II-1: Evidence from well-designed controlled trials without randomization
II-2: Evidence from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group
II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category
III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

A. There is good evidence to recommend the clinical preventive action
B. There is fair evidence to recommend the clinical preventive action
C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making
D. There is fair evidence to recommend against the clinical preventive action
E. There is good evidence to recommend against the clinical preventive action
I. There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making.

• Aim
• Search and appraisal
• Background
• Immediate management of threatened preterm labour
• Other investigations
• Interventions
• Documentation
• Communication
• Longer term management of threatened preterm labour
• Footnotes
• Additional references sourced
• Appendix 1. Assessment and management of preterm labour: Flowchart
• Appendix 2. Levels and grades of evidence

Aim

This guideline aims to provide consistent evidence-based advice on the management of preterm labour (PTL) at the three level six (tertiary) maternity services in Victoria. Namely, Mercy Hospital for Women, Monash Medical Centre and The Royal Women’s Hospital.

This will be of significant benefit to the women being treated and for the service providers, who receive advice and support from these tertiary maternity hospitals.

It is anticipated that this guideline will be used as a basis for the development of guidelines at other hospitals; which will take into account local service provision and the needs of the local population.

Search and appraisal

The following methods of search and appraisal were used: An Ovid platform database selection was made using Medline, Embase and Cochrane databases for evidence published in English, mostly from the year 2000 onwards.

Professional body websites were also used, namely: American College of Obstetricians and Gynecologists (ACOG), Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), Royal College of Obstetricians and Gynaecologists (RCOG), Society of Obstetricians and Gynaecologists of Canada (SOGC).

Other websites accessed were: National Health and Medical Research Council (NHMRC), National Institute for Health and Clinical Excellence (NICE) and BMJ Best practice.

Where international guideline groups have cited levels of evidence, these have been referred to in the summary boxes at the conclusion of each section. Also see Appendix 4. Evidence tables.

Search terms used were: "Threatened preterm labour" (labor), "premature", "cervical insufficiency", "cervical shortening", "tocolytics", "preterm birth", "progesterone", "corticosteroids", "neuroprotection" and "fetal fibronectin".

In the compilation of these recommendations, international guidelines and the results of systematic reviews were used to compare facets of care. Contemporary reviews and recommendations from professional bodies were also used. Individual randomized controlled trials were used if they were a high level of evidence using NHMRC evidence level grading criteria.

Published guidelines from each of the three level six (tertiary) maternity hospitals were gathered, then compared and contrasted against the international reviews and guidelines.

Following an iterative consultation process among key stakeholders from the three level six hospitals, a consensus of opinion was gained in most instances. In cases of conflicting points of view, a variance process was initiated whereby the Co-Chairs of the 3centres Collaboration made the final decision. 

Background

Definition

The World Health Organization defines preterm or premature birth as the birth of an infant before 37 completed weeks of gestation.¹ However preterm birth at the earlier gestations have the most clinical impact. 

Preterm labour can be confirmed in the following order: by gestation, (where accurate gestational dating is available from an early ultrasound scan) by the last menstrual period or in preterm birth, by fetal weight. The following generally accepted classifications can be useful for planning on-going management and predicting or discussing neonatal outcomes. 

34- 37 weeks gestation: Preterm
28-34 weeks gestation: Very preterm
<28 weeks gestation: Extremely preterm

There is no set lowest gestation to this definition, but 23–24 weeks gestation is widely accepted, which approximates to an average fetal weight of 500g.² 

The care and management of women in labour on the cusp of viability (22-23 weeks) will not be covered in this guideline.

Incidence

Around 10% of all births in Australia are before 37 weeks gestation.³ Preterm birth, particularly at the lower gestations, is associated with an increased risk of perinatal mortality and morbidity, including disability in surviving children.⁴  

Risk Factors

One in three preterm births are unexplained and spontaneous (30%) however, one known association for idiopathic preterm labour, is low socioeconomic status.^5,6,7

Known risk factors for preterm labour and birth include: 

• previous preterm birth
• preterm rupture of membranes
• multiple pregnancy 
• antepartum haemorrhage
• systemic infections 
• genital tract infections 
• cervical insufficiency
• congenital uterine abnormalities

Around 15-20% of preterm births are due to iatrogenic or elective preterm births, usually for maternal medical complications including hypertensive disorders or fetal growth restriction.⁸ 

Immediate management of threatened preterm labour

History

On presentation, a thorough assessment of the woman should be undertaken and include:

• the estimated date of delivery (EDD). The current gestational age should be established preferably by early ultrasound, (<14 weeks) which overrides the calculation of the EDD using the last normal menstrual period (LMP). If the first ultrasound has been performed >14 weeks, and differs by >7 days from the LMP, the EDD should be calculated from the LMP.⁹ 
• predisposing risk factors for preterm labour or birth 
• symptoms of labour, such as contractions, ascertain their duration, strength and regularity
• associated symptoms of labour, for example lower back pain
• symptoms of ruptured membranes, antepartum haemorrhage or a “show”

Examination

A maternal examination should be performed with a focus on the following:

• maternal observations i.e. temperature, blood pressure and pulse.
• abdominal palpation to assess uterine tone, tenderness or contractions; to assess duration, strength and regularity. 
• palpation to assess fetal size, lie, presentation and station. 
• vaginal speculum examination using sterile gloves and a sterile speculum. Sterile water should be used as a lubricant to allow the fetal fibronectin (fFN) test to be performed accurately (see below).¹⁰ 
• high vaginal swabs should be taken be taken for bacteriological assessment and a low vaginal/ano-rectal swab for group b streptococcus screen. 
• digital vaginal examination to assess effacement, dilatation and station. If the membranes are thought to be ruptured, a digital examination should be avoided until labour is established. (also see www.3centres.com.au/guidelines/PPROM)

Note – In all situations, it is advisable to avoid a digital cervical examination until after a speculum examination has been performed so that a fFN test can be carried out; as a digital examination will affect the result of this test. 

If the woman has a cervical suture and is in established preterm labour, confirmed by the presence of regular (painful) contractions, accompanied by cervical change or has preterm prelabour rupture of the membranes, prompt removal of the cerclage is indicated.  

If time permits and transfer to a hospital that is able to provide neonatal services appropriate for her gestation is required, following consultation with PERS, it may be prudent to consider leaving the cerclage in situ and using tocolysis in transit.

Fetal Fibronectin Test (fFN)

Fetal fibronectin (fFN) is an appropriate screening test to use in women presenting with preterm uterine activity, to predict the likelihood of birth within the next 7 days. It may also assist in the decision-making regarding transfer of a woman to a hospital with neonatal facilities appropriate for her gestation.¹¹

A negative fFN test has a very high negative predictive value: 99.5% of women with a negative result will not give birth spontaneously in the 7 days following the test. 

Because of the high negative predictive value for preterm birth, there is no evidence to support keeping a woman in hospital with a negative fFN test, unless her circumstances require admission or clinical situation changes significantly. 

The predictive value of a positive fFN test is less clinically useful and may not enhance clinical decision making, with the positive predictive value of 13-30% for preterm birth in the next 7 days.¹² 

Any cervical manipulation within the previous 24 hours, such as coitus, digital vaginal examination and transvaginal ultrasound examination, may affect the test outcome.

Fetal fibronectin is also found in blood, semen and liquor, the presence of which may also cause a false positive result. However, this should not dissuade the clinician from performing the test, as a negative result in these circumstances can still be relied upon.

If a symptomatic woman with a positive fFN result is not already in a hospital with appropriate neonatal facilities for her gestation, is symptomatic with a positive fFN result, the clinician is advised to consult with the Victorian Perinatal Emergency Referral Services (PERS) regarding the appropriateness for transfer. Tel: 1300137650.

Fetal fibronectin table

Other investigations

Maternal investigations

Dependent upon the woman’s gestation and if time permits, an ultrasound scan may be used to confirm presentation, assess fetal weight, morphology (if not already performed) and amniotic fluid index (AFI).

A Full Blood Count (FBC) should be considered as part of a general screen for infection as a cause of preterm labour.

A mid stream urine for laboratory culture and sensitivity should be collected. Other sources of infection should be considered and investigated as necessary.

Fetal Investigations

Cardiotocograph (CTG); Continuous electronic fetal heart rate monitoring should be used when a woman is in preterm labour.¹³ There is a possibility that fetal compromise has been the trigger for preterm labour and it is also possible that the preterm fetus will have reduced reserves and may be more susceptible to hypoxia associated with contractions. 

CTG monitoring between 26-28 weeks is more difficult to interpret, as the physiological adaptations that affect the heart rate pattern in a term fetus, have not yet fully matured at this gestation. Preterm infants have a baseline heart rate towards the upper end of the range 110-160bpm. Accelerations have less amplitude and are of shorter duration.

History, examination and investigations summary table

Interventions

Corticosteroids

If preterm birth less than 34 weeks is anticipated within the next 7 days, corticosteroids should be administered as soon as possible, unless birth is imminent. 

Corticosteriods are now widely administered for prophylaxis against neonatal respiratory distress syndrome, a single course of betamethasone is given to women with a gestation of between 23 to 34 weeks. The course is administered as two intramuscular (I.M.) injections of 11.4 mg of betamethasone given 24 hours apart.¹⁴  

While there is compelling evidence that antenatal corticosteroids improve neonatal outcomes when used before 34 weeks gestation, to date the evidence for the optimal drug, dose, route and timing remain unclear.

Antenatal corticosteroid use reduces neonatal death even when infants are born less than 24 hours after the first dose has been given.

The results from one small trial suggest that dexamethasone is more effective in reducing the rate of neonatal intraventricular hemorrhage when compared with betamethasone. 

Therefore, should betamethasone be unavailable, clinicians may choose to use dexamethasone as an alternative. It is administered as 6mg I.M. every 12 hours for 4 doses.¹⁵ 

There is currently insufficient evidence regarding the potential risks and long-term effects to recommend the use of repeated doses of corticosteroids in clinical practice, and results from trials with long-term follow-up are required. If a repeat dose of antenatal corticosteroid is contemplated, then caution is advised and senior obstetric opinion should be sought. 

If the original indication for the risk of a premature birth is resolved, or 34 weeks gestation is reached, then no further doses are required.

The results from the Australasian Collaborative Trial of Repeat Doses of Corticosteroids for the Prevention of Neonatal Respiratory Disease (ACTORDS) trial will further assist in guiding practice.¹⁶

Antibiotics

If the woman’s membranes are intact and there is no other indication for use, antibiotics should not be routinely given, as there is no evidence that they prolong gestation or improve neonatal outcomes. 

Further, there is some evidence that suggests antibiotics in this instance are implicated in possible harm, with an increase in the number of children with functional impairment whose mothers were exposed to erythromycin. The use of amoxicillin/clavulanic acid in women with intact membranes has also been associated with an increase in the numbers of babies born with cerebral palsy and is therefore not recommended until further evidence can guide practice.¹⁷

Antibiotics for systemic infection

If there are signs of systemic infection or chorioamnionitis, the antibiotic treatment should be broad and given according to local protocols. There is no definitive drug or duration of treatment however, an example of a common treatment regimen is: 

Amoxicillin or ampicillin 2 grams intravenously I.V. every 6 hours;
Plus

Gentamicin 4 to 6mg/kg I.V. for one dose then a maximum of one or two further doses, based on renal function;
Plus 

Metronidazole 500 mg I.V. every 12 hours to provide additional anaerobic coverage. 

In women allergic to penicillin, give: Clindamycin or Lincomycin 600mg I.V. every 8 hours.¹⁸

Systemic infection antibiotics summary box

Prophylactic antibiotics for Group B Streptococcus (GBS)

If the woman is being treated for a systemic infection, the antibiotics prescribed should replace GBS-specific antibiotic prophylaxis.

GBS specific antibiotics: Penicillin 1.2g I.V. bolus followed by 600mg I.V. every 4 hours. If the woman is allergic to penicillin, give Clindamycin or Lincomycin 600mg  I.V. every 8 hours.

If a woman’s GBS status is unknown the following risk factors for GBS infection should guide treatment with appropriate antibiotics.

• previous infant with early-onset GBS disease
• GBS bacteriuria in the current pregnancy
• Positive for GBS on a low vaginal anorectal swab in the current pregnancy
•  prolonged rupture of membranes (an interval of 18 hours or more between rupture and birth)
• preterm labour at less than 37 weeks of gestation
• maternal temperature higher than 38 ̊C.

Antibiotics are not indicated in the following circumstances:

• regardless of GBS status- antibiotics are unnecessary if the membranes are intact, providing there is no systemic infection and if labour is not established.
• antibiotic prophylaxis for GBS is also unnecessary for women with preterm rupture of membranes unless she is in established labour.  

Prophylactic antibiotics for GBS summary box  

TOCOLYSIS

Aim 

The use of tocolysis to prolong pregnancy has not shown to improve perinatal morbidity or mortality. The primary indication of tocolytic treatment for women who are in preterm labour is to postpone birth for 48 hours in order to allow the optimal effect of maternal corticosteroid treatment. If required, it will also facilitate in the transfer of a woman to a hospital with neonatal facilities appropriate for her gestation.

There is currently no evidence to support the role of maintenance therapy beyond the initial 48 hours.

There is no high quality evidence to show that tocolysis improves perinatal outcomes. By suppressing labour in a potentially adverse fetal environment or with an unknown cause for the preterm labour, it could be harmful. For this reason some clinicians may choose not to use tocolysis. 

Nifedipine 

If tocolysis is used, the tocolytic agent of choice unless contraindicated, is the calcium channel blocker nifedipine. While nifedipine is not approved for use in pregnancy and is classified as a risk category C drug by the Australian Drug Evaluation Committee, it is the most commonly used first line tocolytic therapy.¹⁹ 

The onset of action is usually 30 – 60minutes. It is not recommended that a second line tocolytic drug be considered in the first two hours after giving nifedipine.

Dosage  

Give an initial dose of 20mg of nifedipine tablet orally (not slow or controlled release nifedipine). 

After 30 minutes, if contractions persist, give another 20mg nifedipine oral dose. 

After a further 30 minutes, if still contracting, follow up with a further 20mg orally.

If the woman’s blood pressure is stable, a maintenance dose of 20mg nifedipine orally, eight hourly for 48 hours may be given where indicated. The maximum dose of nifedipine is 160mg/day. 

Observations

Half hourly maternal pulse and blood pressure until the contractions cease. Maternal hypotension should be treated with IV fluids in the first instance.

Continuous electronic fetal heart rate monitoring should be carried out until contractions have settled. 

Contraindications 

Tocolysis should be used with extreme caution and in consultation with experienced advice in suppression of labour where there is an antepartum haemorrhage (APH), preeclampsia, abnormal fetal CTG recording, maternal cardiac disease including cardiac conduction defects, left ventricular failure and hypotension. 

Clinicians must weigh the possibility of a preterm birth and the sequelae of a preterm infant against the risk of suppressing labour in order to gain time for fetal lung maturation, but with the possibility of a precarious maternal or fetal situation evolving. 

While seldom reported in clinical practice, there is a potential interaction between magnesium sulphate (MgSO₄) and nifedipine, resulting in hypotension and neuromuscular blockade effects. If severe hypotension occurs, nifedipine and MgSO₄ administration should be ceased.

Side effects 

Numerous side effects to nifedipine use have been reported. These include: 

• hypotension that may affect blood supply to the uteroplacental bed and cause an alteration in fetal heart rate. Maternal hypotension should be treated promptly and CTG monitoring used to observe the fetal effect. 
• maternal facial flushing, headache, nausea, tachycardia, dizziness, and hypotension. 

The clinician, in consultation with the woman must decide whether the benefits outweigh these unpleasant side-effects.

Nifedipine regimen

Tocolysis summary box

Magnesium sulphate for neuroprotection

Although high-level evidence is limited regarding the use of magnesium sulphate as a neuroprotectant, recent meta-analyses have suggested that magnesium sulphate given before preterm birth may be neuroprotective for the fetus.²⁰ 

It is not recommended that magnesium sulphate for neuroprotection is used for those women who are awaiting transfer or who are in transit to an appropriate hospital.

Magnesium sulphate may be considered for use in women at high risk of birth before 30 weeks gestation, or whose birth is planned or anticipated within 24 hours and who are already in a hospital where neonatal facilities are appropriate for her gestation, irrespective of:

• the number of babies in utero 
• the reason the woman is in preterm labour
• the parity
• the anticipated mode of birth
• whether or not corticosteroids have been given   

If it has been decided to give MgSo4 then the recommended dosing regimen is: 

• a 4g loading dose given intravenously, slowly over 20-30 minutes
• a 1 g/hour maintenance dose. 
• This should be continued up until birth or for 24 hours, whichever comes first. 
• If birth no longer appears to be imminent the infusion is stopped, but can be restarted as indicated.²¹

While seldom reported in clinical practice, there is a potential interaction between magnesium sulphate (MgSO₄) and nifedipine, resulting in hypotension and neuromuscular blockade effects. If severe hypotension occurs, nifedipine and MgSO₄ administration should be ceased.

Magnesium sulphate for neuroprotection summary box

Documentation 

Ensure that all documentation is contemporaneous and thorough. 

Communication

If time permits, the woman and her family should have the opportunity to discuss the birth, management plan and expected outcomes for the infant once it is born. It is important to ensure the woman and her family are all adequately informed of the clinical situation, in a manner that they will understand.

Longer term management of threatened preterm labour

When the immediate assessment and management is complete and contractions have ceased, consider a transvaginal ultrasound examination for cervical length and assessment of fetal wellbeing, including biometry. If the fetus is found to be growth restricted, umbilical artery Dopplers to assess fetal well-being can also be performed.

 Subsequent pregnancy

Women who have previously experienced a preterm birth, should be reviewed by an obstetric consultant in the next pregnancy. Dependant upon the circumstances of the preterm birth, additional tests, investigations and management options should be discussed and considered. 

Footnotes

[1] World Health Organisation. Available from: www.who.int/reproductivehealth
[2] Haas DM, Preterm Birth, BMJ Clin Evid (Online). 2008 Jun 2; 2008. www.clinicalevidence.bmj.com
[3] Laws PJ, Li Z & Sullivan EA 2010. Australia’’s mothers and babies 2008. Perinatal statistics series no. 24. Cat. no. PER 50. Canberra: AIHW.
[4] The Consultative Council on obstetric and paediatric Mortality and Morbidity (CCopMM) Annual report available from www. health.vic.gov.au/ccopmm/downloads/ccopmm_annrep07.pdf
[5] Bloom SL, Yost NP, McIntire DD, et al. Recurrence of preterm birth in singleton and twin pregnancies. Obstet Gynecol 2001;98:379–385.
[6] Durnwald CP, Walker H, Lundy JC, Iams JD. Rates of recurrent preterm birth by obstetrical history and cervical length. Am J Obstet Gynecol. Sep 2005;193(3 Pt 2):1170-4
[7] Goldenberg R. et al, Epidemiology and causes of preterm birth The Lancet, 2008, Volume 371, Issue 9606, Pages 75-84
[8] Iannucci TA, et al. Etiology and outcome of extremely low-birth-weight infants. Am J Obstet Gynecol 1996;174:1896–1902
[9] Maternity and Newborn Clinical Network, Victorian standard for induction of labour. Depart. Of Health, Victoria. (undated) Available from: www.health.vic.gov.au/clinicalnetworks/downloads/maternity/victorian_standard_for_induction_of_labour.pdf
[10] www.ffntest.com/pdfs/SpecimenCollectionMultilingual.pdf
[11] Capability framework for maternity and newborn services, Dept. of Health, Victoria. Available from: www.health.vic.au/maternitycare
[12] The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Use of cervical fetal fibronectin as a screening tool for preterm birth. College Statement. C-Obs 26. 2008 [Cited November 2010]. Available from: http://www.ranzcog.edu.au/publications/statements/C-obs26.pdf
[13] RANZCOG Intrapartum Fetal Surveillance Clinical Guidelines. Available from: www.ranzcog.edu.au/fsep/practical_guide.shtml
[14] Brownfoot FC, Crowther CA, Middleton P. Different corticosteroids and regimens for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD006764. DOI: 10.1002/14651858.CD006764.pub2
[15] Elimian A, Antenatal betamethasone compared with dexamethasone (betacode trial): a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):26-30
[16] Crowther CA, Doyle LW, Haslam RH, Hiller JE, Harding JE, Robinson JS for the Australasian Collaborative Trial of Repeat Doses of Steroids (ACTORDS) Study Group  Outcomes at Age 2 Years following a Randomized Trial of Repeat Doses of Antenatal Corticosteroids, N Engl J Med 2007;357:1179-89
[17] Kenyon S et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet. 2008 Oct 1;372(9646):1319-27
[18] Pelvic inflammatory disease: Severe infection [revised June 2010]. In: eTG complete [Internet]. Melbourne: Therapeutic Guidelines Limited; Accessed Feb. 2010 www.tg.org.au
[19] King JF, Flenady V, Papatsonis D, Dekker G, Carbonne B. Calcium channel blockers for inhibiting preterm labour. Cochrane Database of Systematic Reviews 2003, Issue 1. Art. No.: CD002255. DOI: 10.1002/14651858.CD002255
[20] Doyle LW, Crowther CA, Middleton P, Marret S, Rouse D. Magnesium sulphate for women at risk of preterm birth for neuroprotection of the fetus. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD004661. DOI: 10.1002/14651858.CD004661.pub3
[21] The Antenatal Magnesium Sulphate for Neuroprotection Guideline Development Panel. Antenatal Magnesium Sulphate Prior to Preterm Birth for Neuroprotection of the Fetus, Infant and Child: National Clinical Practice Guidelines 2010 Feb. Available at: www.adelaide. edu.au/arch/antenatalMagnesium_SulphateGuidelines.pdf .

Additional references sourced

ACOG, Society for Maternal-Fetal Medicine. Committee Opinion No. 455: Magnesium sulphate before anticipated preterm birth for neuroprotection. Obstet Gynecol. 2010 Mar;115(3):669-71.

V, Hayes E, Visintine J, Baxter JK. Fetal fibronectin testing for reducing the risk of preterm birth. Cochrane Database Syst Rev 2008:CD006843.

Berghella V, et al, Gestational age at cervical length measurement and incidence of preterm birth. Obstet Gynecol. 2007 Aug;110(2 Pt 1):311-7

Bloom SL, Yost NP, McIntire DD, et al. Recurrence of preterm birth in singleton and twin pregnancies. Obstet Gynecol 2001;98:379–385.

Conde-Agudelo A, Romero R. Antenatal magnesium sulphate for the prevention of cerebral palsy in preterm infants less than 34 weeks' gestation: a systematic review and metaanalysis. Am J Obstet Gynecol. Jun 2009;200(6):595-609.

Crowther CA. Hiller JE. Doyle LW. Haslam RR. Australasian Collaborative Trial of Magnesium Sulphate (ACTOMg SO4) Collaborative Group  - Effect of magnesium sulfate given for neuroprotection before preterm birth: a randomized controlled trial. JAMA. 290(20): pp. 269-76 (2003) 

Farine D, et al, Maternal Fetal Medicine Committee, Society of Obstetricians and Gynaecologists of Canada. The use of progesterone for prevention of preterm birth. J Obstet Gynaecol Can 2008 Jan;30(1):67-71.

Honest H, Bachmann LM, Gupta JK, Kleijnen J, Khan KS. Accuracy of cervicovaginal fetal fibronectin test in predicting risk of spontaneous preterm birth: systematic review. BMJ. 2002 Aug 10;325(7359):301

Jobe AH, Soll RF. Choice and dose of corticosteroid for antenatal treatments. Am J Obstet Gynecol. 2004;190:878.

Newnham J, et al. Should we be prescribing repeated courses of antenatal corticosteroids? Semin Fetal Neonatal Med. 2009 Jun;14(3):157-63. Epub 2008 Dec 21. Gynecol. 2007 Aug;110(2 Pt 1):311-7.

Queensland Statewide Maternity and Neonatal Clinical Guideline: Assessment and management of preterm labour Available from: www.health.qld.gov.au/cpic/documents/matguide_preterm4.2.pdf.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (2006) Intrapartum Fetal Surveillance Clinical Guidelines available from: www.ranzcog.edu.au/publications/womenshealth

Appendix 1. Assessment and management of preterm labour: Flowchart

(Print as a pdf)

Appendix 2. Levels and grades of evidence

NHMRC body of evidence matrix

RCOG levels and grades of evidence 

SOGC levels of evidence

BMJ Clinical Practice evidence levels

BMJ CLINICAL EVIDENCE METHODS USED.

BMJ Clinical Evidence search and appraisal June 2007. The following databases were used to identify studies for this systematic review: Medline 1966 to June 2007, Embase 1980 to June 2007 and The Cochrane Library (all databases) 2007, Issue 2. Additional searches were carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) for all databases, Turning Research into Practice (TRIP), and NICE. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the author for additional assessment, using pre-determined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews and RCTs in any language, at least single blinded (if possible), and containing at least 20 individuals of whom more than 80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as “open”, “open label”, or "not blinded" unless blinding was impossible. In addition we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. We have performed a GRADE evaluation of the quality of evidence for interventions included in this review.

Download Preterm labour quick guide (pdf)

• Aim
• Comparison of International Guidelines
• Search and Appraisal
• Definition and Incidence of APH
• Classification of APH

• Emergency Management of a Major APH
• APH Where Immediate Resuscitative Measures are not Required
• APH Footnotes
• APH additional references sourced

• Placenta Praevia
• Definition and diagnosis of placenta praevia
• Incidence of placenta praevia
• Presentation and effects of placenta praevia
• Hospital or home management for women with placenta praevia
• Management of birth for women with placenta praevia; including vaginal, caesarean section and anaesthesia
• Thromboprophylaxis
• Placenta accreta, percreta, increta and management choices
• Placenta praevia Footnotes
• Placenta praevia additional references sourced

• Placental Abruption
• Definition, incidence, risk factors and diagnostic features for placental abruption
• Initial management of placental abruption
• Investigations for placental abruption
• On-going management of placental abruption
• Conservative management of placental abruption
• Fetal demise following placental abruption
• Abruption Footnotes
• Abruption additional references sourced

• Vasa Praevia
• Definition, incidence, risk factors, clinical presentation and management

• Cervical and lower genital tract bleeding

• Appendix 1. APH - Quick Reference Guide
• Appendix 2. Clinical Evidence Tables

Download Quick guide (pdf)

Aim

This guideline aims to provide consistent advice for the evidence-based management of antepartum haemorrhage (APH) across the three level six (tertiary) maternity services in Victoria. This will be of significant benefit to the women being treated and for the primary and secondary service providers, who receive advice and support from these tertiary maternity centres.

It is anticipated that this guideline will be used as a basis for the development of local guidelines, which will take into account local service provision and the needs of the local population.

Comparison of International Guidelines

To compile this guideline, international guidelines from obstetric groups were used to compare facets of care pertaining to antepartum haemorrhage, diagnosis and treatment.

An evidence-based model has been extrapolated from the consensus of opinion between these international guideline groups. Where opinion was absent or equivocal, the highest level of evidence from systematic reviews has been used.

Published guidelines from each of the three tertiary centres, namely Mercy Hospital for Women, The Royal Women's Hospital and Southern Health's Monash Medical Centre were gathered, then compared and contrasted against the international model.

Following an iterative consultation process among key stakeholders, a consensus of opinion was gained in most instances. In cases of conflicting points of view, a variance process was initiated, whereby the Co-Chairs of the 3centres Collaboration made the final decision.

Search and Appraisal

The following methods of search and appraisal were used:

An Ovid platform database selection was made using Medline, Embase, Cochrane library and the Clinicians Health channel to access on-line journals and databases for systematic reviews of evidence or the results of randomised controlled trials.

Guidelines developed by specific, international guideline groups were also searched via the Internet.

Search terms used were; “Guidelines”, “antepartum haemorrhage (hemorrhage)”, “placenta praevia (previa)”, “placental abruption”, “placentae abruptio”, “vasa praevia (previa)” and “vaginal bleeding”.

The basis of international guideline selection was: The publication after the year 2000 and international guidelines published by obstetric and gynaecology professional bodies.

The areas of clinical care covered in this guideline include:

• definition and incidence of APH
• causes of APH outlined
• emergency management of a major APH
• causes and specific management of APH
  • Placenta Praevia
  • Abruption
  • Vasa Praevia
  • Cervical and lower genital tract bleeding
• quick reference guides

Definition and Incidence of APH

Obstetric haemorrhage (both antepartum and postpartum haemorrhage) is one of the leading causes of maternal mortality in the developed world.

Antepartum haemorrhage (APH) is defined as any bleeding from the genital tract after the 20^th week of pregnancy and before the onset of labour. Some of the causes of antepartum haemorrhage might also cause intrapartum bleeding, such as an abruption or placenta praevia.

Antepartum haemorrhage complicates 2-5% of all pregnancies. It is associated with increased rates of perinatal morbidity and mortality and contributes to significant healthcare costs.¹

Classification of APH

Classification of an APH is according to the site of bleeding and is commonly defined as follows:

Placenta Praevia (Accounts for about 30% of APH cases) and it is bleeding from a placenta located in the lower uterine segment.

Placental abruption (Accounts for about 25% of APH) is bleeding from a normally situated placenta. This may be a marginal bleed (bleeding from the placental edge or margin) or in association with significant placental separation.

Vasa Praevia is a rare condition in which umbilical blood vessels traverse the fetal membranes of the lower uterine segment, unsupported by the umbilical cord or the placenta. Bleeding from these vessels is almost always associated with rupture of the fetal membranes.

Cervical and lower genital tract bleeding (Accounts for about 45% of APH) includes bleeding from any site within the genital tract and include:

Cervical lesions such as an ectropion, dysplasia, cervicitis, polyps or carcinoma.

Cervical bleeding in pregnancy may occur spontaneously, or follow sexual intercourse, a clinical examination or Pap smear. Bleeding from the lower genital tract is uncommon.

On occasion, bleeding from the urinary tract (haematuria) or ano-rectum (e.g. haemorrhoids) may be confused with an APH. Taking a complete history and conducting an appropriate clinical examination will greatly assist the clinician in making the correct diagnosis.

Regardless of the site of bleeding, women presenting with an APH may be broadly divided into two groups: Those with a major haemorrhage and those with an APH where immediate resuscitative measures are not required.

Emergency Management of a Major APH

The majority of women presenting with an APH will not require immediate resuscitation. However, the actual blood loss is often more than is immediately apparent from haemodynamic assessment (e.g. pulse and blood pressure). This is because otherwise healthy women are well able to compensate for acute loss without overt signs or symptoms of shock.

Early resuscitative measures are important, particularly if there has been substantive blood loss. These include control of bleeding, restoration of circulating blood volume for oxygenation of tissues and diagnosing and treating the underlying cause of the bleeding. The required urgency of assessment and the escalation of treatment will largely depend upon the amount of bleeding, haemodynamic stability of the woman, her degree of shock, gestation and general maternal and fetal wellbeing.

An important part of resuscitation in a major APH is replacing the blood cells lost, with the transfusion of blood products. All hospitals should have a massive transfusion protocol that may be initiated for women with a major APH. Also, all hospitals should have a protocol on the management of women who refuse blood products.

Prompt assessment is imperative. Members of the treating team including an experienced obstetrician, anaesthetist, haematologist and other assistance as needed may carry out the following actions simultaneously.

The following principles will assist in the prompt assessment and management of a major APH:

History and initial assessment

• assess the woman's general condition - Record pulse, blood pressure, temperature, respiratory rate and oxygen saturation level. NB. A healthy adult may maintain vital signs within the normal range until shortly before a critical point is reached and then suddenly and rapidly deteriorate.
• record history – Expected due date, history of any bleeding in pregnancy, other relevant history e.g. recent trauma. 
• check blood group, Rhesus and antibody screen, ultrasound scan results for placental site.
• note blood loss (amount, consistency and colour). It has been shown that practitioners often underestimate the volume of blood loss, particularly when blood loss is large.²
• considerable blood loss may be contained within the uterus (concealed), therefore the volume of visible blood may not be an accurate representation of the total amount of blood being lost. A tense tender uterus may signify the presence of concealed blood.
• if there has been a severe abruption (tense, tender uterus with a fetal death in utero), consider an early blood transfusion. 
• additional support – Midwives, obstetric staff, anaesthetist, haematologist and neonatologist.

Basic Life Support

• if required, establish an airway and administer oxygen therapy or assist ventilation.
• infuse fluids at approximately the rate that blood is being lost. In initial resuscitation, fluid replacement with crystalloid is as effective as with colloid.³ 
• insert an in-dwelling urinary catheter with urometer. Record hourly urine output.
• if blood component therapy is indicated and consented to, advice should be sought from a haematologist regarding appropriate therapy.
• in the absence of a massive transfusion protocol or specialist haematology advice, consider the following:

Fluid replacement and fluid balance

• IV access. One or two size 16 gauge or larger bore cannulae. 
• infuse fluids at approximately the rate that blood is being lost. In initial resuscitation, fluid replacement with crystalloid is as effective as with colloid.
• insert an in-dwelling urinary catheter with urometer. Record hourly urine output.
• if blood component therapy is indicated and consented to, advice should be sought from a haematologist regarding appropriate therapy.
• in the absence of a massive transfusion protocol or specialist haematology advice, consider the following:

If maternal haemodynamic state can only be improved by delivery, this should be considered, irrespective of gestational age.

Emergency management summary box

 APH where immediate resuscitative measures are not required

 Initial Assessment

 The following history should be ascertained:

Presenting Features

• timing and amount of blood loss – e.g. number of pads used with an estimation of the blood staining on each pad
• associated features – e.g. abdominal pain and contractions
• provoking factors – e.g. trauma or sexual intercourse
• fetal movements since the bleeding has started
  

Current Pregnancy

• previous episodes of bleeding in the current pregnancy
• review of any ultrasound examinations performed earlier in pregnancy, particularly noting placental site recorded on a 20 week (or later) scan

Past obstetric, gynaecological, medical and surgical history.

Examination

An examination should be performed, checking the following:

• the woman's general condition - record pulse, blood pressure and temperature. For a non major APH, the vital signs should be within the normal ranges.
• abdominal Palpation – checking for uterine tenderness and symphysis-fundal height, fetal lie and presentation.
• vaginal examination with a speculum only, to assess the site of bleeding.

 Blood investigations 

• collect blood for: Full blood count (FBC), blood group and cross-match at least two units in case the bleeding escalates to a major APH, coagulation profile to detect any unsuspected thrombocytopaenia, Kleihauer-Betke test or flow cytometry for an estimation of feto-maternal haemorrhage and confirm amount of Anti-D immunoglobulin required if the woman is Rhesus negative. 

 Fetal well-being assessment 

• cardiotocogragh (CTG) or hand held Doppler, if an appropriate gestation has been reached. If not reached, fetal well-being can be confirmed with an ultrasound scan.

Ultrasound scan

• ultrasound scan for placental location, to exclude placenta praevia.
• an ultrasound scan is not the investigation of choice to diagnose a placental abruption. Unless there is substantive placental separation, and this will be clinically apparent, a placental abruption is not likely to be seen on ultrasound.

Medications

• the need for analgesia should raise concerns of a moderate or severe placental abruption, or that the woman is in labour. Offer analgesia and antiemetics if required.
• give corticosteroids if gestation is less than 34 weeks. (Two doses of Betamethasone 11.4mg, 24 hours apart).
• administer 625iu Anti-D, as an intramuscular injection, if the woman is Rhesus D negative. Additional doses of Anti-D immunoglobulin may be required if the Kleihauer-Betke test indicates a large feto-maternal haemorrhage.
• if birth is imminent at a gestation less than 30 weeks gestation, consider a magnesium sulphate infusion for fetal neuroprotection.⁴

Placenta Praevia

Definition and Diagnosis

Placenta praevia is when the placenta is inserted wholly or partly into the lower segment of the uterus in the third trimester of pregnancy.

The diagnosis of placenta praevia is made by transvaginal ultrasound, where the distance between the inferior edge of the placenta and the internal cervical os is measured.

If the placenta lies over the cervical os, it is considered a major placenta praevia; otherwise it is considered a minor placenta praevia. This diagnosis has evolved from the original clinical (I–IV) grading system.

Trans-vaginal or trans-labial ultrasound is the preferred method for localisation of a low-lying placenta. They have been shown to be significantly more accurate than using trans-abdominal sonography and it is safe to perform, even in the presence of bleeding. It is easier to identify an anterior than a posteriorly located placenta praevia. This is because the fetus often obscures the leading edge of a posterior placenta.

When a woman is found to have a low lying placenta that reaches or overlaps the cervical os at her 18-20 week morphology ultrasound scan, a further trans-vaginal ultrasound scan in later pregnancy is required, to confirm the diagnosis of placenta praevia. The timing of the second ultrasound scan for placental localisation should be:

• in cases of asymptomatic suspected minor placenta praevia - follow-up imaging can be arranged for 32 to 36 weeks. The earlier the ultrasound scan is performed the more likely it is to find an ongoing placenta praevia however, a later scan may lead to unnecessary clinical uncertainty.

• in cases with asymptomatic suspected major placenta praevia, a trans-vaginal ultrasound scan should be performed at 30-32 weeks. This is to clarify the diagnosis, to check for the presence of a vasa praevia, and to allow planning for third-trimester management and delivery.

• women who are symptomatic - should be managed individually according to their needs.

Incidence

A low lying placenta occurs in 5% of pregnancies at 16-18 weeks gestation but are evident in only 0.5% pregnancies at term.¹  The change of placental position results from the formation of the lower uterine segment and which moves the placenta upwards with the expanding uterus. The incidence of placenta praevia is higher in women with a previous caesarean section and increases in prevalence with each caesarean section.² 

Presentation

Women with a placenta praevia generally present in the following ways:

• with an antepartum haemorrhage.
• as a finding on ultrasound in an asymptomatic woman.
• with a fetal malpresentation or a high mobile presenting part in late pregnancy.
• with vaginal bleeding in labour

Effects of placenta praevia

The most common pregnancy complication arising from a placenta praevia is intermittent vaginal bleeding. About 70-80% of women with a placenta praevia will have at least one episode of vaginal bleeding, irrespective of whether the placenta praevia major or minor.³ Bleeding may also lead to maternal anaemia and so it is worthwhile ensuring and maintaining adequate maternal haemoglobin levels and iron stores. Bleeding is more likely to occur in the third trimester when the lower uterine segment is developing or during contractions with cervical dilatation, which is thought to cause shearing forces, leading to disruption of the placental attachment. Bleeding can also be provoked by a digital examination or intercourse.⁴

From the second trimester, a placenta praevia may be associated with vasa praevia and therefore localisation of the fetal vessels on a follow up ultrasound scan is advised.¹

Bleeding caused by a placenta praevia may lead to maternal (as documented above) and fetal effects, such as hypoxia related to decreased blood supply to the placental bed, which leads to an abnormal cardiotocograph. Bleeding will lead to the need to deliver the fetus in a small number of cases.

Fetal effects of placenta praevia, that are seen in the longer term, may include intrauterine growth restriction (IUGR), due to abnormal placental implantation and vascularisation in the area of the uterus destined to be the lower segment; and a higher incidence of premature prelabour rupture of the membranes (PPROM), which is thought to be as a result of the blood affecting the integrity of the membranes.

Triggers for delivery caused by placenta praevia (i.e. in addition to other routine reasons) can be summarised as:

Placental abruption

Definition

Abruption is an antepartum haemorrhage from placental separation from the myometrial wall. The bleeding may be may be revealed, when blood escapes through the vagina, or concealed, when the bleeding occurs behind the placenta, with no evidence of bleeding from the vagina. When there is revealed bleeding it is also likely that there is a significant concealed proportion of bleeding. There are degrees of abruption that will reflect the range of maternal and fetal compromise.

Placental abruption is associated with a high maternal and neonatal morbidity and mortality.

 Incidence

Placental abruption complicates around 1% of pregnancies.

Risk factors

Risk factors for placental abruption include:

• Factors predisposing to an abruption such as chronic hypertension, preeclampsia, thromobphilia, previous placental abruption, smoking, cocaine use.
• Chorioamnionitis
• Sudden reduction in size of an over-distended uterus e.g. rupture of the membranes in association with polyhydramnios, between births of multiple pregnancies
• Trauma e.g. motor vehicle accident. A woman involved in trauma, such as an MVA, should be evaluated for abruption. An abruption may occur in the absence of direct abdominal trauma or, an abruption may become apparent several hours or days after the trauma.

Diagnostic features

A placental abruption most commonly presents with bleeding associated with a variable degree of abdominal pain.  This is in contrast to the painless bleeding of placenta praevia or bleeding from the cervix or lower genital tract. However, some placental abruption can also be painless.  Abruption should be high on the differential diagnosis list whenever abdominal pain occurs in the second half of pregnancy. Back pain may also be another common symptom.

Where the abruption is substantive, the uterus may be tender on palpation or may feel hard or tense. Fetal parts might not be felt through the tense uterus. Symptoms, signs and clinical examination finding of preterm labour may also coexist with abruption.

In some cases fetal demise may be the only indication of an abruption or could be accompanied by any of the previously listed symptoms.

Initial management

A detailed history should be taken if possible, to ascertain if the woman has any risk factors for abruption, including predisposing factors for placental insufficiency or any recent trauma A detailed routine history should be taken. 

The revealed blood loss should be estimated and clinical signs (blood pressure, pulse) evaluated. Urine output should be at least 30 mL/hour.  An indwelling urinary catheter with a urometer will assist with accurate measuring of output.

The following principles should guide the need for blood transfusion:

• Revealed loss is likely to underestimate total blood loss
• In the presence of a typical severe abruption (with fetal death), the woman may require 4-6 units of blood due to the concealed haemorrhage.
• Considerable further blood loss should be anticipated around the time of birth. Blood replacement should be directed towards stabilising the maternal condition so that the woman is capable of sustaining further blood loss. (See management of a major APH)

An abruption should be considered if there has been recent abdominal trauma. In this situation, fetal monitoring should be carried out for a minimum of 4 hours.¹

If there are uterine contractions, abnormal fetal heart rate tracings, vaginal bleeding, uterine tenderness, or rupture of the membranes, further evaluation and/or delivery are indicated as determined by gestational age and individual circumstances.

Investigations

Maternal investigations:

• Palpation: Contractions are often frequent with a short resting period between the contractions. 
• Haemoglobin, coagulation studies to exclude disseminated intravascular coagulopathy as a consequence of large blood loss. Note that Fibrinogen levels rise in pregnancy therefore ‘normal’ or low fibrinogen levels and a prolonged prothrombin time are suggestive of disseminated intravascular coagulation (DIC).
• Ultrasound: In severe abruptions, there may be evidence of a retroplacental haematoma, increased placental thickness or echogenicity however, ultrasound is not the investigation of choice as there may be no ultrasound findings in the presence of an abruption.

• Kleihauer –Betke test or flow cytometry as a measure of feto-maternal haemorrhage.

Fetal investigations:

• Cardiotocograph.

Abruption on-going management

Corticosteroids and Magnesium Sulphate

Should be given for fetal lung maturation in pregnancies less than 34 weeks gestation, Two doses of Betamethasone 11.4mg, 24 hours apart, if delivery is not planned within the next 12 hours.

Magnesium sulphate should be considered for neuroprotection in pregnancies where delivery is planned at less than 30 weeks gestation.²  

Timing of Birth

Factors that should be taken into consideration:

• Gestational age
  • Severity of abruption as judged by: The volume of revealed blood loss and clinical signs and symptoms of haemorrhagic shock.
  • Features of concealed blood loss such as abdominal pain & tenderness
• Fetal well-being e.g. cardiotocography
• Co-existent conditions that may have be associated with the abruption such as preeclampsia or placental insufficiency of unknown origin.

For women at or near term, even if the current abruption appears to be minimal, delivery is recommended in view of fetal maturity. This is due to the risk of further, possibly catastrophic placental abruption.

At premature (32-37 weeks) gestations, conservative management can be considered for what appears to be only a minor placental abruption.  However, if there is substantive revealed blood loss, significant uterine tenderness, evidence of coagulopathy or fetal compromise, delivery should be expedited.     

At very premature (28-32 weeks) and extreme preterm (less than 28 weeks) gestations, conservative management may considered, even in the presence of substantive revealed bleeding or significant uterine tenderness – but only if both maternal and fetal conditions are stable. The timing of birth must weigh the risks of the maternal condition and prematurity, against those of continuing the pregnancy.

Mode of birth

If either the fetus or woman are unstable, delivery should take place promptly, with concurrent stabilisation of both. This is usually by caesarean section unless vaginal delivery is imminent and can be achieved safely. In significant abruptions, neonatal morbidity is improved if the decision to delivery time for caesarean section is less than 20 minutes, therefore unnecessary delay should be avoided.

If the abruption is significant but the woman is stable and the CTG is normal, then vaginal delivery can be attempted. Often the woman is having contractions, but if she is not in active labour, induction usually results in delivery. Continuous electronic fetal heart rate monitoring is strongly recommended, as is the availability of blood products in the event of catastrophic bleeding.

Tocolysis

For women with abruption who are bleeding and contracting, tocolysis is controversial and should only be used with caution by experienced clinicians.

Conservative management after a placental abruption

Place of Management

In all cases, the woman will be initially admitted to hospital and many will remain as inpatients until birth.  However, after a period of assessment, some women may be discharged home and monitored as an outpatient providing that:

• The initial bleeding has completely abated and there is no evidence of ongoing haemorrhage. 
• Clinical features were those of a minor placental abruption (low volume revealed blood loss and minimal uterine tenderness)
• Fetal well-being is reassuring

Fetal Surveillance

All pregnancies that have had a placental abruption require intensive fetal surveillance. The woman should be carefully advised with respect to the observation of fetal movements and the reporting of any decrease in fetal activity. 

A regimen of regular cardiotocography and serial ultrasound scans is appropriate and should be tailored according to the clinical condition.

Fetal demise following a severe placental abruption

If the woman is not in active labour, the labour can be induced by routine methods, providing her condition remains stable. If the maternal condition is worsening, caesarean delivery may be indicated.

In a woman refusing the administration of all blood products but without overt DIC, a caesarean section may avoid the catastrophic situation of a later vaginal birth with massive haemorrhage, DIC and a patient refusing all blood products.  In contrast, if DIC is already established, the conventional wisdom is to avoid adding to the risk of bleeding at the  surgical site to the risk of bleeding at the placental site. 

Postpartum Haemorrhage following a Placental Abruption

Postpartum haemorrhage is relatively common following a placental abruption and may occur as a consequence of both a bleeding disorder (thrombocytopenia +/- DIC) and uterine atony.  The latter may occur in association with a “couvelaire” uterus – where blood has suffused into the myometrium, giving the serosal surface a mottled black appearance. Utero-tonic agents such as oxytocin, ergometrine and prostaglandin analogues may be given, according to the usual contraindications.  Platelets and clotting factors should be replaced.

In severe cases, where bleeding is unresponsive to delivery, utero-tonic administration, platelet and clotting factor replacement surgical measures can be life saving. The following can be considered, according to individual circumstances and local expertise:

• Balloon tamponade (e.g. Bakri)
• Compression sutures (e.g. B-Lynch)
• Surgical ligation of the uterine arteries or the hypogastric arteries
• Selective embolisation of these vessels may arrest this life-threatening haemorrhage.
• Hysterectomy

Abruption Follow-up

Placental pathology may help elucidate the aetiology and pathophysiology of the abruption. Abnormalities such as placental thrombosis, perivillous fibrin deposition, infarction and decidual abnormalities may be found.

Women who have had a placental abruption should be screened for both congenital and acquired thrombophilias.  If the Protein S level is low, it should be repeated after an interval of 6 weeks, as the abnormally low level may be a transient impact of pregnancy. Women who smoke or engage in recreational drug use, should be advised of the strong association with placental abruption.

Abruption Footnotes

1. Oyelese, Yinka MD. ACOG, Obstetrics & Gynecology: October 2006 - Volume 108 - Issue 4 - pp 1005-1016
2. Doyle LW et al, Magnesium Sulphate for women at risk of preterm birth for neuroprotection of the fetus. Cochrane Database of Systematic Reviews 2009, Issue 1. 

 

Abruption additional references sourced

• BMJ-Best Practice www.bestpractice.bmj.com/best-practice.

• Hillemanns P, et al, Crash emergency cesarean section: decision-to-delivery interval under 30 min and its effect on Apgar and umbilical artery pH. Arch Gynecol Obstet. 2005 Dec;273(3):161-5.

• Martel MJ, MacKinnon KJ, Arsenault MY, Bartellas E, Klein MC, Lane CA, Sprague AE, Wilson AK; Clinical Practice Obstetrics Committee and Executive and Council, Society of Obstetricians and Gynaecologists of Canada. Hemorrhagic shock. J Obstet Gynaecol Can 2002;24(6):504-11.

• Martí-Carvajal AJ, Comunián-Carrasco G, Peña-Martí GE. Haematological interventions for treating disseminated intravascular coagulation during pregnancy and postpartum. Cochrane Database of Systematic Reviews 2010, Issue 7. Art. No.: CD008577. DOI: 10.1002/14651858.CD008577.

• Neilson JP. Interventions for treating placental abruption. Cochrane Database of Systematic Reviews 2003, Issue 1. Art. No.: CD003247. DOI: 10.1002/14651858.CD003247.

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Vasa praevia

Definition

Vasa praevia is a condition in which the umbilical vessels, unsupported by either the umbilical cord or placental tissue, traverse the fetal membranes of the lower segment above the cervix.

Incidence 

 The reported incidence varies from 1 in 1275 to 1 in 5000 (0.08% - 0.02%). Vasa praevia usually occurs in association with velamentous insertion of the umbilical cord, bipartite placenta or succenturiate lobe. In the presence of a velamentous insertion of the cord with the placenta in the lower uterine segment, the incidence of vasa praevia has been reported to be 1 in 50.

Risk factors

Placenta praevia, low-lying placenta, and bilobate or succenturiate placenta.

Clinical presentation

When performing a third trimester ultrasound on a woman with a suspected placenta praevia, it is recommended that colour Doppler imaging is also performed specifically to detect the presence of fetal vessels.

 Vasa praevia will extremely rarely present with an “antepartum” haemorrhage.  Detection is more likely on vaginal examination with palpation of fetal vessel, vaginal bleeding at amniotomy or sudden severe abnormalities of the fetal heart rate in labour are more usual presentations.

Management

Antenatal diagnosis and prompt neonatal resuscitation have shown to improve outcomes and the safest form of delivery is caesarean section, prior to the onset of labour.

The optimal gestational age at delivery has not been established. Due to the high rate of fetal mortality, it has been recommended that delivery be considered by 35-36 weeks,¹ but expert clinical judgement for individualized care is necessary.

In the event of vaginal bleeding with a known vasa praevia, if time permits, a rapid biochemical test for fetal haemoglobin could be conducted, followed by an urgent caesarean section if a confirmed result is returned. However, performing a CTG or listening to the fetal heart rate may be a quicker way in many situations, to infer the diagnosis and institute appropriate management. There is typically an initial tachycardia as the fetus first becomes hypovolaemic, soon followed by a sustained bradycardia and then fetal demise if delivery by caesarean section is not immediate.

Vasa Praevia Footnotes

1. Gagnon R et al. SOGC Guidelines for the Management of Vasa Previa. No. 231 August 2009. International Journal of Gynecology & Obstetrics, Volume 108, Issue 1, Pages 85-89

 

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Cervical and lower genital tract bleeding

Other causes of vaginal bleeding in late pregnancy include:

• Heavy show / onset of labour – Bleeding associated with labour is not traditionally considered an Antepartum Haemorrhage. If the cervix is effaced or a dilated and other causes of bleeding are excluded, the bleed is likely to be a "show.”   
• Cervical ectropion / dysplasia/ - Bleeding from the surface of the cervix caused by contact with the speculum and may indicate cervical pathology and warrant further investigation i.e. pap smear, colposcopy. Bleeding from the walls of the vagina may indicate a severe vaginitis.   
• Genital Tract Polyps - Cervical polyps are usually apparent upon speculum examination. 
• Vulval or vaginal varices - Will be apparent upon speculum examination. 
• Trauma - Consider victims of domestic violence and sexual assault.  

Non genital tract causes:

• Haematuria, anal or rectal bleeding. 
• Unexplained bleeding.

Cervical and lower genital tract bleding references

• Geneva Foundation for Medical Education and Research. Maternal Care Manual - Perinatal Education Programme.  Accessed from: www.gfmer.ch/PEP/MCM_Home.htm
• Royal Women’s Hospital Clinical practice Guidelines. Accessed from www. thewomens.org.au

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Appendix 1. APH quick reference guide

APH Quick reference guide

Appendix 2. APH clinical evidence tables

American College of Obstetricians and Gynecologists (ACOG)

Practice Bulletins summarise current information on techniques and clinical management issues for the practice of obstetrics and gynaecology. Practice Bulletins are evidence-based documents, and recommendations are based on the available evidence. The levels of evidence used are as follows:

Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories:

Level A - Recommendations are based on good and consistent scientific evidence.

Level B - Recommendations are based on limited or inconsistent scientific evidence.

Level C - Recommendations are based primarily on consensus American College of Obstetricians and Gynecologists.

Royal College of Obstetricians and Gynaecologists (RCOG)

Green-top Guidelines provide systematically developed recommendations, which assist clinicians and patients in making decisions about appropriate treatment for specific conditions. Green-top guidelines are concise documents, providing specific practice recommendations on focused areas of clinical practice. The Green-top guidelines are produced under the direction of the Guidelines and Audit Committee of the RCOG.

RCOG evidence grades:

A Requires at least one randomised controlled trial as part of the body of literature of overall good quality and consistency addressing the specific recommendation.

B Requires availability of well-conducted clinical studies but no randomised clinical trials on the topic of recommendation.

C Requires evidence from expert committee reports or opinions and/or clinical experience of respected authorities. Indicates absence of directly applicable studies of good quality.

√Good practice point. Recommended best practice based on the clinical experience of the guideline development group.  

Classification of evidence levels:

Ia Evidence obtained from meta-analysis of randomised controlled trials.

Ib Evidence obtained from at least one randomised controlled trial.

IIa Evidence obtained from at least one well designed controlled study without randomisation.

IIb Evidence obtained from at least one other type of well-designed quasi-experimental study.

III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies.

IV Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities.

Royal College of Obstetricians and Gynaecologists UK 2006.  Available from: http://www.rcog.org.uk/files/rcog-corp/uploaded-files/GT10aManagementPreeclampsia2006.pdf (accessed July 2009)

 

The Society of Obstetricians and Gynaecologists of Canada (SOGC).

The levels of evidence are described as:

Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force on Preventive Health Care

I: Evidence obtained from at least one properly randomized controlled trial

II-1: Evidence from well-designed controlled trials without randomization

II-2: Evidence from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group

II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

A. There is good evidence to recommend the clinical preventive action

B. There is fair evidence to recommend the clinical preventive action

C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making

D. There is fair evidence to recommend against the clinical preventive action

E. There is good evidence to recommend against the clinical preventive action

I. There is insufficient evidence (in quantity or quality) to make a recommendation; however,

These guidelines are developed for a "normal healthy woman with an uncomplicated pregnancy".

The following complications usually require additional care from an obstetrician or other specialist:

• Cardiac (heart) disease, including hypertension (high blood pressure)
• Renal (kidney) disease
• Endocrine disorders or diabetes requiring insulin
• Psychiatric disorders (on medication)
• Haematological (blood) disorders, including thromboembolic disease
• Epilepsy requiring anticonvulsant drugs
• Malignant disease (such as cancer)
• Severe asthma
• Chemical dependency
• HIV and HBV positive
• Autoimmune disorders
• Significantly overweight or underweight
• Significant environmental factors and lack of social support
• Recurrent miscarriage or mid trimester loss
• More than 5 previous pregnancies (grand multiparity)
• Severe pre eclampsia
• Rhesus isoimmunisation or other significant blood group antibodies
• Uterine surgery including caesarean section or cone biopsy
• Antenatal or postpartum haemorrhage on two + occasions
• Retained placenta on 2+ occasions
• Growth restriction (IUGR)
• Still birth or infant (neonatal) death
• Birth weight <2500gms or >4500gms
• Congenital abnormality eg Down's syndrome
• Postnatal depression or Puerperal psychosis

• How did we implement the 3centres antenatal guidelines?
• What did we learn?
• Major challenges
• Reflections from the project team

The guidelines outlining the best available evidence for care of Women with Uncomplicated Pregnancy were completed in October 2001.

The challenge then was to apply this evidence across maternity care services in Victoria. The evidence for guideline implementation and practice change recommends properly resourced, multifaceted strategies tailored to local issues and practice and cautions against simplistic strategies, inadequate timeframes and opportunism.

How did we implement the 3centres guidelines?

1. Each tertiary maternity service developed its own plan, and tailored the strategies to the organisational context.

Mercy Hospital for Women and Monash Medical Centre agreed to group the Guidelines into four sets and tackle one set at a time.

Multidisciplinary site teams were convened and they began to meet and identify the barriers and bridges to implementation. A project midwife assisted this process by interviewing across section of staff. She worked with site teams on process redesign, mapping of patient journeys and designing staff supports.

2. The steering group worked on issues such as changing the legislative requirements around midwives offering HIV screening to pregnant women.

3. Shared Care Affiliates, consumers, allied projects, training providers and professional colleges were engaged. A one year project plan incorporating facets and insights from the literature on effective guideline implementation was developed and ran from June 2002-June 2003

Over 1200 Shared Care Affiliates were surveyed for their knowledge of the Guidelines, evidence based practice and for their education needs. An education intervention was then designed specifically for them.  This education program utilised adult education principles and to aimed to help participants:

• Understand the implications of the Guidelines for content and timing of visits
• Implement the Guidelines
• Discuss tests and investigations using effective, woman-centred communication skills
• Train their colleagues

12 interactive and multidisciplinary facilitator training workshops and a special workshop for community providers was provided to address:

• Clinical Content: What the guidelines say or imply
• Communication Skills: How to discuss and offer tests and woman-centred care to women in real world settings
• Culture(s): What are the influential philosophies and values that govern why antenatal care ‘happens’ the way it does? What is the cultural basis of my practice? Common barriers such as “lack of time” and “women don’t want this role” to be discussed and challenged.

The workshops were successful at disseminating the 3Centres Guidelines throughout Victoria, impacting well over 800 health professionals. A total of 218 midwives, clinical educators, GPs and obstetricians attended the 12 workshops. 48% (105) trained as facilitators. Another 400 health professionals were trained in 2003. A total of 230 GPs and Midwives attended the special Melbourne SMCA workshop.

Participants considered the facilitator training workshops useful and 92% said they would recommend it to colleagues. The SMCA workshop, planned on the basis of a needs analysis, received a high ranking with 87% rating it ‘helpful’ or ‘very helpful’.

4. A multifaceted program was designed to support change through the Victorian maternity care system in collaboration with other maternity care projects.  These include:

• Sharing Shared Care Project to develop Process Guidelines for Shared Care Affiliates [2001-2002]
• The Victorian Maternity Performance Indicators Project [2002-2003]
• Various projects to develop web and written evidence based consumer information incorporating the Guidelines [2001-2003]
• Statewide Dissemination and Training Project for the 3Centres Consensus Guidelines on Antenatal Care[2003]
• Development of a Victorian Handheld pregnancy record [2004-2006], and incorporating the "guide to tests and investigations in pregnancy [2006-2009]
• Having a Baby in Victoria website
• Statewide Pregnancy training package

Weaving a Web Poster (PDF)

5. An audit of guideline implementation was conducted (2005) and results feedback to the organizations (2007)

An audit to assess practice consistency (in caring for low risk pregnant women) with guideline recommendations was conducted pre guideline development, 6 months post implementation and 2 years post implementation (Pre – September 1, 2001, Post 1 – December 1, 2003, Post 2 – July 1, 2005).

75 consecutive records of completed pregnancies meeting the inclusion criteria at dates to satisfy the pre implementation and post implementation criteria were selected.

The 3centres outcomes audited were:

• Is there evidence that a discussion took place about models of care?
• Are there any risk factors present? 
• What was the date of the first visit?
• How many visits did this woman have?
• What was the date of delivery?
• Was the woman’s weight recorded?
• Was the woman’s height recorded?
• Was BMI calculated?
• Is BMI between 18 and 35?
• If BMI <18 or >35 is there evidence of management plans?
• HIV – evidence of pre-test discussion?
• Was HIV test performed?
• HEP B – evidence of discussion?
• Was Hep B test performed?
• Hep C – evidence of discussion?
• Hep C – evidence of risk assessment?
  • History of injecting drugs?
  • Partner past or present who injected drugs
  • A tattoo or piercing
  • Been in prison
  • Received blood which later tested positive for Hep C
  • Been on long term haemodialysis
  • Received an organ transplant before July 1992
• Is the woman at high or low risk for Hep C? 
• Is a result for Hep C test recorded? 
• Evidence of discussion about urinalysis at booking?
• Asymptomatic Bacteriuria – evidence of a discussion?
• Was there early screening for ABS?
• Was there evidence of risk screening for renal disease?
• Was there evidence of risk screening for UTIs?
• If evidence of renal disease or UTIs, was MSU collected?
• Which test was performed-dipstick or microscopy and culture?
• If dipstick positive for blood, protein, nitrites and leukocyte esterase was a sample sent for microscopy and culture?
• If GP collected MSU, were results sent to hospital by referring GP?
• At any visit was the woman hypertensive? BP >140/90
• If the women was hypertensive, was urinalysis performed at any of these visits?
• Is there evidence of discussion about prenatal screening?
• Was a prenatal screening test performed?
• If a prenatal screening test was performed, which was it?
• Is there evidence of a discussion about diabetes screening?
• Was a diabetes test performed?
• Was the test OGCT, OGTT or both?
• Is there evidence of discussion about GBS?
• Was a GBS test performed?
• Was the GBS test positive?
• If GBS positive, was the mother or baby treated?

Feedback of audit results was offered to the tertiary maternity services in 2007. These sessions included a group discussion and analysis of barriers to guideline implementation, which were used to develop targetted "enhanced implementation" of selected guidelines. This process is adapted from recommendations from the National Institute of Clinical Studies (NICS).

What did we learn?

• Influencing and changing clinical practice is difficult
• Communicating information and providing education alone is unlikely to change practice. There are complex social dynamics associated with change and multifaceted processes are needed.
• Strong leadership and ongoing commitment is critical and needs to be sustained by ongoing commitment to supporting relationships and actively involving people in the process
• Multidisciplinary training is important in promoting team based care
• A paradigm shift was required to develop more interactive training models
• Incentives (such as professional development points) are important in promoting participation in professional education
• Workshop attendance increased participants' knowledge and uptake of the 3Centres Guidelines in many areas of antenatal practice in the 4-6 weeks immediately following workshops. The pre and post workshop surveys for both facilitator training and the Shared Maternity Care Affiliate [SMCA] workshops demonstrate many positive shifts in antenatal practice in line with Guideline requirements, including the discussion of certain tests with women.
• Workshop attendance increased participants' awareness of the barriers to guideline implementation. Before the workshop more people perceived fewer barriers for fewer guidelines and expected implementation to be very straightforward. Post workshop, the most commonly cited barriers to implementation were tradition, lack of time, lack of knowledge, lack of confidence and opposition or lack of support from colleagues or management.
• Guidelines on HIV screening, number of visits, Down syndrome screening and Smoking Cessation were considered the hardest to implement. These Guidelines and barriers required follow up with targeted strategies and supports.
• Documentation may not reflect actual care given which makes accurate auditing difficult

What were the major challenges?

• High turnover of key staff
• Time pressures
• Lack of resources
• Lack of multidisciplinary training opportunities

Reflections from the project team

• I feel overwhelmed most days.
• I have carried a very big load for this hospital without a lot of support. We have meetings and try to engage people but it has been difficult to put so much work for little reward and little to show for it. 
• This big project has been carried without medical support.
• The preliminary work is done but it is far from implemented in process and culture. Planning is easy. Culture is hard.
• There a lot of little wrinkles that we haven’t sorted out.
• It is so fragile it only works 50% of the shifts. It doesn’t function when we are stretched…this is directly due to staffing. It is not systematised yet. We haven’t grown all the necessary processes.
• There has been a lot of brushing over of issues …we need a daily reminder about what we should be doing and so residents and registrars know what to do.
• Documentation systems have not kept apace with staffing changes eg developing a pregnancy record (this was largely due to the time it took to consult with polarised groups)
• We need a better education strategy. You can’t implement anything if people are not confident and informed about it.
• I have found lack of leadership and ownership really difficult. I find it extremely difficult to have people at the head of the ship not owning them and saying ”Right this is what we are doing.” I go to site meetings and know that we won’t get anywhere because the problems are bigger than the seniority of the people there.
• If it falls over it won’t be because the medical staff sabotaged. It will be because we all got too tired.

• Levels of Evidence
• Guideline Development Team
• Search and Appraisal Teams

The guidelines were developed from 2001-2005 through:

• search & appraisal of the best available evidence (contracted to expert groups including The Centre for Clinical Effectiveness, Monash Institute of Health Services Research, Monash University and The Research and Education Division, Department of Perinatal Medicine, the Royal Women's Hospital)
• consultation with staff and women;
• consensus reached among the joint steering group; and external review.

The Anti Cancer Council of Victoria (ACCV) collaborated on guidelines for smoking cessation interventions. Multidisciplinary reference groups from each centre reviewed the guidelines as they were drafted.

This collaboration was a "first" for the centres concerned and resulted in basic first step guidelines for pregnancy, and in numerous other joint projects. The collaboration ensured higher commitment and progress than individual centres could achieve, and greatly improved communication, understanding and networking between the centres and DHS. The partners learned a great deal about the requirements and tensions in netting the evidence and turning research into workable and acceptable practice guidelines.

Levels of Evidence

The evidence for intervention questions presented in these guidelines was systematically assessed and classified according to the NHMRC's A Guide to the Development, Implementation and Evaluation of Clinical Practice Guidelines (1998) Evidence for other
questions was generally given the equivalent of Level IV status by consensus of the steering group and clinical epidemiologist.

Level I Evidence is obtained from systematic review of all relevant randomised controlled trials
Level II Evidence is obtained from at least one properly designed randomised controlled trial
Level III-1 Evidence is obtained from well-designed pseudo-randomised controlled trials (with alternate allocation or some other method)
Level III-2 Evidence is obtained from comparative studies with concurrent controls and allocation not randomised (cohort studies), case control studies or interrupted time series with a control group
Level III-3 Evidence is obtained from comparative studies with historical controls, two or more single arm studies or interrupted time series without a parallel control group
Level IV Evidence is obtained from case series, opinions of respected authorities, descriptive studies, reports of expert committees and case studies

Guideline Development Team

The following details are of the original team in the guideline development project, and their names appear here as acknowledgement to the work they have done:

Project Team

Coordinator: Joanna Campbell

Steering Group

Christopher Targett
Clinical Director, Maternity Services, Mercy Hospital for Women

Euan Wallace
Associate Professor, Obstetrics and Gynaecology, Southern Health/Monash University

Jan Pannifex
Program Director, Women's Health Program, Southern Health Service

Julie Collette
Clinical Director, Maternity Services, Mercy Hospital for Women

Lisa Dunlop
Director (Acting), Maternity Services Division, Royal Women's Hospital, Women's and Children's Health Service

Lou Butterfield
Director, Maternity Services Division, Royal Women's Hospital, Women's and Children's Health Service

Mary Draper
Manager, Quality and Care Continuity Branch, Effectiveness Unit, Department of Human Services

Wendy Dawson
Senior Project Officer, Quality and Care Continuity Branch, Effectiveness Unit, Department of Human Services

Gil Dwyer
Senior Project Officer (to October 2000), Quality and Care Continuity Branch, Department of Human Services

Kim Hider
Senior Project Officer (to October 1999), Quality and Care Continuity Branch, Department of Human Services

Ro Hogan
Director (to October 2000), Maternity Services Division, Royal Women's Hospital, Women's and Children's Health Service

Search and Appraisal Teams

Centre for Clinical Effectiveness

Jeremy Anderson
Director, Centre for Clinical EffectivenessPaul Fennessey
Head, Health Technology Unit

Elmer Villeneuva
Deputy Head, Health Technology Unit

Vivenne Bernath
Information Officer

Elizabeth Burrows
Information OfficerRenea Johnson
Information Officer

Kim Hender
Information Officer

Alex Rauilli
Research Assistant

Royal Women's Hospital, Division of Research and Education

Hilary Russell
Deputy DirectorJames King
Clinical Epidemiologist

Lyn Rigg
Project Officer

Dr Veronica Miller
Clinical Research FellowAngela Taft
Project Officer
(seconded from the Centre for Studies on Mother's and Children's Health)

Anti-Cancer Council of Victoria

Lisa Trotter
Research and Evaluation Manager Meg Montague
Project Consultant

Special Thanks

Many people provided expert advice and assistance to the project. These include:

Caroline Crowther
Associate Professor, Obstetrics and Gynaecology, Women's and Children's Hospital, AdelaideJane Gunn
Senior Lecturer, Department of General Practice, Melbourne University, Melbourne

Jane Halliday
Director, Perinatal Data Collection Unit, Department of Human Services

Jenny Hunt
Centre for Studies on Mother's and Children's Health, La Trobe University, Melbourne

Judith Lumley
Director, Centre for Studies of Mothers and Children's Health, La Trobe University, Melbourne

Hilda Bastian
Cochrane Consumer Collaboration

James King
Clinical Epidemiologist and Associate Professor, Department of Perinatal Medicine, Royal Women's Hospital, Melbourne

Jane Yelland
Centre for Studies on Mother's and Children's Health, La Trobe University, Melbourne

• review by each organisations guideline committees
• education for staff
• publication on maternity service intranet systems

New guidelines have been disseminated statewide through the Maternity and Newborn Clinical Network.

• Guideline development
• Search and appraisal

Guideline Development

These guidelines were developed through:

• searching and appraising international guidelines to compare facets of care.  A ‘Best Practice’ model has been extrapolated from the consensus of opinion between the international guideline groups. Where opinion was absent or equivocal, the highest level of evidence has been used;
• comparing and contrasting published guidelines from each of the three tertiary centres, namely Mercy Hospital for Women, The Royal Women’s Hospital and Southern Health’s Monash Medical Centre against the international best practice model;
• an iterative consultation process among key stakeholders, a consensus of opinion was gained in most instances;
• in cases of conflicting points of view, a variance process was initiated whereby the Co-Chairs of the 3centres Collaboration made the final decision.

Search and appraisal methods

An Ovid platform database selection was made using Medline, Embase, Cochrane library and the Clinicians Health channel used to access on-line journals and databases.

Guidelines developed by specific, international guideline groups were also searched via the internet. 

The specific objectives for 2009-11 are:

1. To provide regular bimonthly forums for multidisciplinary leaders which model collaborative behaviour within the group and with other stakeholders, including MNCN, PERS and the Department
2. To support informal networking which facilitates synergy between other maternity service projects, through the Maternity Project Community of Practice
3. To provide an advisory role for PERS
4. To maintain, update and disseminate high quality consumer information
5. To establish and maintain formal collaborative relationships with the MNCN and other stakeholders to represent tertiary maternity service issues, clarify the roles for tertiary maternity services and investigate areas of mutual concern
6. To improve the consistency of evidence based practice and uniformity of guidelines within tertiary maternity services, with initiatives which have benefits across the system

These are outlined in more detail in the 3centres strategic plan 2009-11 (pdf).

Details of activities being undertaken to achieve these objectives are outlined in the 3centres workprogram 2009-11 (pdf).

Completed work programs:
3centres work program 2006-9 (pdf)
3centres work program 2003-5 (pdf)

Annual reports

The 3centres Collaboration reports annually to the Department of Health. 

Copies of these reports are available below:

3centres annual report 2009-10 (pdf)
3centres annual report 2008-9 (pdf)
3centres annual report 2007-8 (pdf)
3centres annual report 2006-7 (pdf)
3centres annual report 2006 (pdf)
3centres annual report 2005 (pdf)

• Safe and scientific. The safety and wellbeing of mothers and babies is fundamental to all maternity care. Care is based on relevant, evidence-based research and reviewed regularly.
• Woman centred. Women are acknowledged as individuals who differ in their needs, values and preferences. Informed choice is an integral part of maternity care decision-making.
• Equitable and accessible. Maternity care is available to women regardless of socioeconomic or cultural background, disability or place of residence.
• Cost effective. Maternity care is delivered in an efficient and cost effective manner
• Collaborative. Obstetricians, midwives, general practitioners and allied health staff adopt a multidisciplinary team approach to care, consultation and referral.
• Every woman is a partner in the decision-making process. Her support network is acknowledged and valued.
• A positive learning experience. Women are prepared for pregnancy, birth and parenting. Doctors, midwives and allied health staff learn, practice and improve their skills. Women are consulted regularly regarding experiences of care.

The implications of these principles for guidelines can be seen in the recommendation that screening tests are "offered" rather than "performed".

All guidelines contain recommendations that women receive written information in an appropriate language and format and are given an opportunity to discuss procedures and the implications of a positive result prior to those tests. This corresponds to principles of woman-centred and collaborative pregnancy care.

• Aim
• Comparison of international guidelines with current 3centres guidelines
• Search and Appraisal
• Introduction
• Risk factors and prevention
• Classification
• Management
• References
• Download preeclampsia guideline or quickguide

1. Aim

The aim of this guideline is to standardise the care for women with hypertension in pregnancy, preeclampsia and eclampsia among the three tertiary centres providing maternity services in the State of Victoria, and to provide a guideline for use in other hospitals where required.

The guideline will assist doctors and midwives in their decision making in the detection, treatment and care of women with hypertension in pregnancy, and those who present with or develop preeclampsia and/or eclampsia.

It is anticipated that this guideline will be used as a basis for the development of local guidelines, which will take into account local service provision and the needs of the local population.

2. Comparison of International guidelines with current 3centres guidelines

To compile this guideline, four international guidelines were used to compare facets of care pertaining to hypertension in pregnancy, preeclampsia, and eclampsia diagnosis and treatment.

A ‘Best Practice’ model has been extrapolated from the consensus of opinion between the international guideline groups. Where opinion was absent or equivocal, the highest level of evidence has been used.

Published guidelines from each of the three tertiary centres, namely Mercy Hospital for Women, The Royal Women’s Hospital and Southern Health’s Monash Medical Centre were gathered, then compared and contrasted against the international best practice model.

Following an iterative consultation process among key stakeholders, a consensus of opinion was gained in most instances. In cases of conflicting points of view, a variance process was initiated whereby the Co-Chairs of the 3centres Collaboration made the final decision. (Appendix 1.)

3. Search and Appraisal

The following methods of search and appraisal were used:

An Ovid platform database selection was made using Medline, Embase, Cochrane library and the Clinicians Health channel used to access on-line journals and databases.

Guidelines developed by specific, international guideline groups were also searched via the internet.

Search terms used were; ‘Guidelines”, “Preeclampsia”,” “Eclampsia”, ‘Hypertension in Pregnancy’, “Toxaemia”, “PIH”, “Hydralazine”, “Magnesium Sulphate”.

The basis of international guideline selection was: The publication year being after 2000, international credibility (published by obstetric and gynaecology professional bodies) and evidence based practice. (Appendix 2.)

4. Introduction

Severe hypertensive disorders of pregnancy are associated with high rates of maternal and fetal morbidity and mortality. Preeclampsia is a multi-system disorder with unpredictable presentation and progression. Although the clinical progression is usually slow, occurring over days and sometimes weeks, rapid deterioration may occur and occasionally result in multisystem failure within a few hours. There is no curative treatment apart from birth, and the best management is by the involvement of a multidisciplinary team, comprising of an obstetrician, anaesthetist, experienced midwives and possibly haematologist, physician and nephrologist.

5. Risk factors and prevention of preeclampsia

There is no single test to predict the occurrence of preeclampsia; however it has been shown that women may benefit from a risk stratification model to identify those at greatest risk of developing the disease.

At the antenatal booking visit, women should be assessed for the following risk factors for preeclampsia and appropriate specialist referrals should be made, preferably before 20 weeks gestation.

5.1 High risk factors

• preeclampsia in a previous pregnancy
• multiple pregnancy
• pre-existing medical condition: - hypertension, diabetes, antiphospholipid antibody syndrome, renal disease.

Evidence levels B-D SOGC

5.2 Additional risk factors

Further, the risk of preeclampsia is increased in the following group of women. Additional antenatal surveillance is recommended for these women:

• obesity, BMI > 35
• vascular & connective tissue disorders
• maternal age <18 or >35
• nulliparity
• family history of preeclampsia
• new partner. 

Evidence levels B-D SOGC

5.3 Preventative supplements for women with a high risk of preeclampsia

In women with a high risk of developing preeclampsia, studies have shown the benefit of prescribing low dose aspirin (75-150mg/day) from before 16 weeks to at least 37 weeks gestation.

Oral calcium supplementation for those with a proven low dietary intake (<600mg/day or corresponding to less than two dairy servings per day) has also been shown to reduce the incidence of preeclampsia.

There is insufficient evidence to support advising dietary salt reduction, increased exercise or bed-rest. Aspirin for the prevention of preeclampsia in low risk women is not supported.

• low dose aspirin 75-150mg/day
• Calcium 1g/day.

Evidence level l SOGC

6. Classification and diagnosis of hypertensive disorders of pregnancy

The following classifications summarise current evidence and are consistent with most international guidelines. The term PIH should no longer be used as its meaning is unclear.

6.1 Taking blood pressures

A manual sphygmomanometer should be used in preference to an automated devise as the latter can underestimate systolic pressures.

To accurately assess blood pressure, an appropriately sized cuff for the arm should be selected. A large cuff with an inflatable bladder covering 80% of the arm circumference should be used, if the upper arm circumference is greater than 33 cm.

The woman should be sitting comfortably with her feet on a hard surface.

The systolic blood pressure is accepted as the first sound heard (Korotkoff 1) and the diastolic blood pressure is the disap pearance of sounds completely (Korotkoff 5). Where Korotkoff 5 does not occur, Korotkoff 4 (muffling) is accepted. Hypertension is confirmed by serial readings over several hours.

• appropriately sized cuff
• woman sitting with feet on a hard surface
• manual sphygmomanometer
• use Korotkoff 5 for diastolic reading
• take serial readings over several hours.

Evidence level A-B RCOG

6.2 Chronic hypertension

• Essential hypertension: systolic  ≥  140mmHg and/or diastolic  ≥  90mmHg confirmed before 20 weeks gestation, of unknown cause.
• Secondary hypertension: Raised blood pressure as above caused by known pre-existing medical conditions.
• White coat hypertension: A raised blood pressure as above, in the presence of a medical attendant.  

Evidence level  ll SOGC

6.3 Gestational hypertension

Characterised by a new onset raised blood pressure after 20 weeks gestation, without maternal or fetal signs or symptoms of preeclampsia

• Mild to moderate hypertension:  Blood pressure systolic ≥ 140mmHg and/or diastolic ≥  90mmHg
• Severe hypertension: Blood pressure systolic  ≥ 160-170mmHg and/or diastolic ≥ 110mmHg.  

Evidence level  ll SOGC

6.4 Preeclampsia

Preeclampsia is a multi-system disorder arising after 20 weeks gestation. The usual manifestation is hypertension and proteinuria, although proteinuria is not mandatory in order to confirm the diagnosis. Suspicion of evolving or established preeclampsia may arise when hypertension is accompanied by one or more of the following signs and symptoms. (Peripheral oedema is not included in the diagnostic tools, as many pregnant women who develop oedema do not necessarily have preeclampsia.)

Preeclampsia classification

• Mild to moderate: Defined as systolic blood pressure of 140mmHg and/or diastolic blood pressure of 90mmHg or higher measured on at least two occasions over several hours, combined with proteinuria >300 mg total protein in a 24-h urine collection, or ratio of protein to creatinine >30 mg/mmol).
• Severe preeclampsia: Defined as systolic blood pressure 160-170 and/or diastolic blood pressure of 110mmHg or higher measured on at least two occasions over several hours, combined with proteinuria >300 mg total protein in a 24-h urine collection, or ratio of protein to creatinine >30 mg/mmol.  All usually accompanied by other haematological, neurological, hepatic or renal derangement.

6.5 Maternal symptoms and investigations that support a diagnosis of preeclampsia:

The diagnosis of preeclampsia can be made only after clinical examination and laboratory testing using pregnancy specific ranges. Once a diagnosis is confirmed, the management is largely based upon the findings and the gestational age. Serum uric acid levels were once routinely used as an indicator of preeclampsia; more recent studies have questioned their lack of sensitivity and specificity. Therefore caution is advised when using serum uric acid as a diagnostic tool.

Renal:

• proteinuria: ≥ 1+ on dipstick  
• proteinuria confirmed by laboratory testing of a spot urine protein/creatinine ratio  of ≥ 30mg/mmol or 24 hour urine collection ≥ 300mg
• oliguria i.e. <500mL/24 hours or <20mL/hour
• serum or plasma creatinine > 0.09mmol/L or 90µmol/L.
• rapid weight gain with or without generalised oedema.

Haematological:

• thrombocytopaenia. platelet count < 100x10⁹
• coagulation profile derangement (only taken if platelet count is low)
• HELLP syndrome (haemolysis, elevated liver enzymes, and low platelet count)
• disseminated intravascular coagulation. (DIC)

Hepatic:

•  nausea and/or vomiting
• upper abdominal pain, often at the right upper quadrant
• raised serum transaminase >70iu/L.

Neurological:

• headache and/or visual disturbances
• hyperreflexia with clonus
• convulsions (eclampsia).

Evidence level ll SOGC

6.6 Potential fetal consequences of hypertension and preeclampsia:

Complications arising from preeclampsia include placental insufficiency, which can lead to high levels of fetal morbidity and mortality. While there is a focus on maternal manifestations, the following fetal characteristics should not be overlooked, as they may aid the diagnosis and are part of the assessment.

• Reduced fetal movements.
• Abnormal fetal heart rate on cardiotocograph (CTG)
• Reduced amniotic fluid index (AFI)
• Asymmetrical growth restriction
• Increased resistance, absent or reversed end diastolic flow on umbilical artery Doppler
• Low biophysical profile score.

Evidence level ll SOGC

6.7 Preeclampsia superimposed on chronic hypertension

• Women with pre-existing hypertension with or without proteinuria before 20 weeks gestation, who later develop symptoms or signs of preeclampsia.

Evidence level ll SOGC

6.8 Pre-existing hypertension

Is a strong risk factor for the development of preeclampsia. Superimposed pre eclampsia is diagnosed when one or more of the features of preeclampsia develop after 20 weeks gestation in a woman with chronic hypertension.

6.9 Eclampsia

Eclampsia occurs in 1 in 200-300 women with preeclampsia in Australia. It is unpredictable and often there are no associated clinical precursors. Seizures may occur antenatally, intra-partum or postnatally, usually within 24 hours of birth but occasionally later. A differential diagnosis of eclampsia should be made until other medical, metabolic and neurological conditions have been excluded.

• New onset of grand mal seizure activity +/- unexplained coma during pregnancy, intra-partum or in the early post partum period.
• The woman may or may not have signs or symptoms of preeclampsia.

Evidence level ll SOGC

7. Management of hypertensive disorders of pregnancy

The basis of management is stabilisation, assessment, observation and if appropriate, delivery.

The frequency and place of surveillance is based upon the gestation, the severity and rate at which the condition advances.

Maternal surveillance can be as frequent as daily to weekly as a hospital in-patient, an outpatient or as part of a home care program. Similarly, fetal surveillance varies from between daily to second weekly dependent upon test performed, results, gestation and severity of disease.

7.1 Maternal and fetal surveillance

Maternal : Frequency - daily to weekly.

• review for new symptoms or signs
• blood pressure
• urinalysis for protein
• preeclampsia blood screen. i.e. FBE, urea and creatinine, liver function tests.

Fetal: Frequency - daily to 2^nd weekly.

• CTG
• fetal umbilical artery Doppler
• AFI
• growth (2^nd weekly).

Evidence level A-B RCOG, Evidence level B, Evidence level ll

7.2 Place of care

Following a period of initial observation, there is no evidence to support keeping women with mild preeclampsia in antenatal hospital beds.

Depending on disease progression and severity, women can be safely monitored at home or in a day assessment centre, if there is a robust programme with good compliance.

Women with severe preeclampsia must be cared for as a hospital in-patient.

• Mild preeclampsia - Home or day assessment centre.
• Moderate to severe preeclampsia - In hospital.

Evidence level B SOGC, Evidence level ll

7.3 Anti hypertensive maintenance treatment.

The use of antihypertensive therapy in cases of mild preeclampsia is equivocal and its use may compromise placental perfusion. It should only be used in the presence of other disease markers or existing co-morbidities, such as type one diabetes, chronic hypertension, renal or vascular disease.

When blood pressures begin to exceed 140/90mmHg, closer surveillance and consultation with senior colleagues is recommended before commencing antihypertensive therapy. In the future, results of on-going studies will assist in guiding practice.

There is insufficient evidence to recommended one oral antihypertensive over another. The medications of choice are labetalol, methyldopa and nifedipine.

The drug of choice should depend on the clinician's experience and familiarity with a particular drug and on what is known about its adverse effects for both the woman and her baby.

• When blood pressures exceed >140/90mmHg, increase surveillance and consult with senior colleagues before the commencement of antihypertensive therapy. Evidence level C
• Definitely commence antihypertensive therapy with blood pressures > 160/100mmHg

Evidence level A

Evidence level ll SOGC

7.4 Antihypertensive medication for urgent control of severe hypertension

Research has concluded that intravenous Labetalol is the first drug of choice for the urgent control of severe hypertension in pregnancy. This is likely to be due to its lower incidence of adverse effects and therefore, its use supplants that of hydralazine; avoid in women with asthma or congestive heart failure. Its use will depend on availability and the clinicians experience and familiarity with the drug.

The optimum blood pressure range to achieve and maintain is: 140-160/90-100mmHg. Blood pressure should be monitored continuously and reduced gradually to avoid adverse fetal side effects from a rapid decrease in uteroplacental perfusion. Continuous electronic fetal monitoring should be performed concurrently, until optimal blood pressures are maintained.

Evidence level A RCOG, Evidence level ll

7.5 Prophylaxis of eclampsia

Magnesium Sulphate (MgSO4) is the drug of choice for eclampsia and is recommended for women as seizure prophylaxis in cases of severe preeclampsia. Although uncommon, Magnesium toxicity can occur and Magnesium levels should be assessed if signs of toxicity are apparent.

MgSO4 should be continued for at least 24 hours following birth or the last seizure, whichever is later.

Phenytoin and benzodiazepines should not be used for eclampsia prophylaxis or treatment, unless there is a contraindication to MgSO4, or it is ineffective.

7.6 Monitoring during MgSO4 infusion

• ½ hourly blood pressure, pulse, respiratory rate in the acute phase
• 1 hourly patellar reflexes
• 1 hourly urine output measurement + 4 hourly testing of urinary protein
• 2 hourly temperature
• continuous electronic fetal monitoring.
• ECG and oxygen saturation monitoring should be considered

Evidence level lll RCOG

7.7 MgSO4 signs of toxicity

While magnesium toxicity is relatively uncommon, women with renal impairment are at a greater risk of toxicity while receiving a MgSO4 infusion.

• Suppression or loss of patellar reflexes
• Respiratory depression
• Drowsiness
• Loss of consciousness

To treat toxicity, stop the infusion and give Calcium Gluconate 1 g (10 ml) IV over 10 minutes. Take Magnesium levels to confirm that altered state is due to MgSO4 and not another cause.

Evidence level  l RCOG

7.8 Corticosteroids for fetal lung maturation

• Recommended if <34 weeks gestation. 11.4mg intramuscular injection of Betamethasone daily for two doses.

Evidence level l RCOG

• Clinicians may also consider administering antenatal glucocorticoids to women at 34-36weeks' gestation.

Evidence level Good practice point RCOG, Evidence level ll

7.9 Indications for expediting birth

• Severe preeclampsia is an indication for delivery regardless of gestation. However in mild or moderate preeclampsia, conservative management should be considered and particularly so if <34 weeks gestation

Evidence level A RCOG

• If 34–36 weeks gestation with non-severe preeclampsia, there is insufficient evidence to make a recommendation about the benefits or risks of expectant management. Evidence level  lll SOGC 
• If ≥ 37 weeks, women with severe or non severe preeclampsia – expediting birth should be considered.

Evidence level  lll SOGC, Evidence level ll

7.10 Mode of birth

• If ≥ 34 weeks gestation, vaginal birth is optimal, if possible.
• If <32 weeks gestation, the success of induction is reduced and a caesarean section may be necessary.

Evidence level  ll SOGC, Evidence level ll

7.11 Third stage of labour

Ergometrine and Syntometrine are to be avoided in women with hypertension, as the vasoconstrictor effect of Ergometrine increases blood pressure. They could however be considered if post partum haemorrhage occurs.

Active management of the 3^rd stage with 10iu of intramuscular oxytocin. (Syntocinon®)

Or alternatively, 5iu may be given as a slow intravenous injection.

Evidence level RCOG-Good practice point, Evidence level ll

7.12 Fluid management

Pulmonary oedema from excessive fluid administration is a major cause of maternal morbidity and mortality in cases of severe preeclampsia/eclampsia. A strict limit to fluid intake should be adhered to and input/output carefully documented.

The benefits of using frusemide or dopamine for oliguria are inconclusive. They are not recommended for antenatal or intrapartum use but may be of some benefit during the post partum period.

• strict fluid balance charting
• restrict total fluid intake to 80mL/hr
• in severe preeclampsia/eclampsia – An indwelling urinary catheter with hourly urometer
• observe for oliguria - <20mL/hour for 3 or more hours
• observe for pulmonary oedema

Evidence level Good practice point  RCOG

 7.13 Regional analgesia/anaesthesia

• regional analgesia/analgesia is appropriate in the absence of a coagulopathy.
• preloading of fluids is not advised
• pre-referral to an anaesthetist is recommended

Evidence level A ACOG

7.14 Post partum care

In cases of preeclampsia and eclampsia, blood pressure can rise in the first 3-6 postpartum days before it begins to normalise. It can however take several weeks before the blood pressure returns to normal.

The incidence of postpartum eclampsia should not be underestimated, 44% of all cases of eclampsia occur in the postpartum period.

• MgSO4 should continue for a minimum of 24 hours following birth or after the last seizure which ever is later
• antihypertensives should be titrated down
• maintain blood pressure < 160/110mmHg
• In cases of severe preeclampsia, 4 days of inpatient care is prudent.

Evidence level C RCOG

7.15 Follow up

• Appropriate and timely communication with the community health provider, who should continue to monitor blood pressures and manage antihypertensive therapy.
• Severe preeclampsia:- 6 week obstetric review.
• Refer to appropriate specialist if there is persistent hypertension or proteinuria.
• Preconception counselling for subsequent pregnancies.

Evidence level Good practice point RCOG

8. References

Abalos E, Duley L, Steyn DW, Henderson-Smart DJ. Antihypertensive drug therapy for mild to moderate hypertension during pregnancy. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD002252. DOI: 10.1002/14651858.CD002252.pub2.

Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002;359:1877-90.

American Journal of Health Pharmacy. Pharmacotherapeutic Options for the Treatment of Preeclampsia  Available from:  http://www.medscape.com/viewarticle/590260 accessed Aug. 2009

Chronic hypertension in pregnancy. ACOG Practice Bulletin No. 29. American College of Obstetricians and Gynecologists. Obstet Gynecol 2001;98: 177-l 85 (Level III)

Cote AM, Brown MA, Lam E, von Dadelszen P, Firoz T, Liston RM, Magee LA. Diagnostic accuracy of urinary spot protein:creatinine ratio for proteinuria in hypertensive pregnant women: systematic review BMJ. 2008;336(7651):1003-6.

Duley L, Henderson-Smart DJ, Meher S. Drugs for treatment of very high blood pressure during pregnancy. Cochrane Database of Systematic Reviews 2006, Issue 3.

Koopmans CM et al, Accuracy of serum uric acid as a predictive test for maternal complications in pre-eclampsia: Bivariate meta-analysis and decision analysis. European Journal of Obstetrics & Gynecology and Reproductive Biology, Volume 146, Issue 1, September 2009, Pages 8-14

Magee L, Sadeghi S, von Dadelszen P. Prevention and treatment of postpartum hypertension. Cochrane Database of Systematic Reviews 2005, Issue 1.

Milne F et al The pre-eclampsia community guideline (PRECOG): how to screen for and detect onset of pre-eclampsia in the community BMJ MAR2005; 330: 576-580

Podymow T, August P. Update on the Use of Antihypertensive Drugs in Pregnancy, Hypertension, Apr 2008; 51: 960 - 969.

Poon et al, Hypertensive disorders in pregnancy: screening by uterine artery Doppler imaging and blood pressure at 11-13 weeks. Ultrasound Obstet Gynecol. 2009 Nov; Vol. 34 (5), pp. 497-502.

Royal College of Obstetricians and Gynaecologists Guidelines: Preeclampsia – study group statement. Sep. 2003 www.rcog.org.uk/index.asp?PageID=312 accessed Aug. 2009.

The Geneva Foundation for Medical Education and Research Obstetrics, gynecology and reproductive medicine guidelines Pregnancy Preeclampsia, eclampsia. Available from: http://www.gfmer.ch/Guidelines/Pregnancy_newborn/Preeclampsia_eclampsia_hypertension_in_pregnancy.htm accessed Aug. 2009

Appendix 1.

Summary of agreement across the international guidelines groups and 3 tertiary centres, before initiation of the variance process.

Appendix 2.

International guideline groups

The Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) was renamed in 2004, following an amalgamation with the Association for the Study of Hypertension in Pregnancy 9ASSHP), and The Obstetric Medicine Group of Australasia (OMGA).

SOMANZ ‘Guidelines for the management of hypertensive disorders of pregnancy’ were published in 2008. The recommendations are the result of a multidisciplinary working party convened by the Society of Obstetric Medicine of Australia and New Zealand. They reflect current medical literature and the clinical experience of members of the working party. There are 161 references but no levels of evidence were cited.

Guidelines for the management of hypertensive disorders of pregnancy’ Available from: http://www.somanz.org/ accessed July 2009.

The Society of Obstetricians and Gynaecologists of Canada (SOGC).

The guideline ‘Diagnosis, Evaluation, and Management of the Hypertensive Disorders of Pregnancy has been reviewed and approved by the Hypertension Guideline Committee and approved by the Executive and Council of the Society of Obstetricians and Gynaecologists of Canada.

It was published in the Journal of Obstetrics and Gynaecology in March 2008. It contains 397 references and the levels of evidence are described as:

Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force on Preventive Health Care

I: Evidence obtained from at least one properly randomized controlled trial

II-1: Evidence from well-designed controlled trials without randomization

II-2: Evidence from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group

II-3: Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category

III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

A. There is good evidence to recommend the clinical preventive action

B. There is fair evidence to recommend the clinical preventive action

C. The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making

D. There is fair evidence to recommend against the clinical preventive action

E. There is good evidence to recommend against the clinical preventive action

I. There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making

 Journal of Obstetrics and Gynecology of Canada. Available from: http://www.sogc.org/guidelines/documents/gui206CPG0803.pdf (2008) accessed July 2009

American College of Obstetricians and Gynecologists (ACOG)

Practice Bulletins summarise current information on techniques and clinical management issues for the practice of obstetrics and gynaecology. Practice Bulletins are evidence-based documents, and recommendations are based on the available evidence.

‘The diagnosis and management of preeclampsia and eclampsia’ practice bulletin was published in the International Journal of Gynecology and Obstetrics in January 2002.

The summary of recommendations contains evidence levels and there are 63 references. The levels of evidence used are as follows:

Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories:

Level A - Recommendations are based on good and consistent scientific evidence.

Level B - Recommendations are based on limited or inconsistent scientific evidence.

Level C - Recommendations are based primarily on consensus

American College of Obstetricians and Gynecologists. Practice Bulletin no.33 January 2002. International Journal of Gynecology & Obstetrics 77 (3002) 67-75

Royal College of Obstetricians and Gynaecologists (RCOG)

Green-top Guidelines provide systematically developed recommendations, which assist clinicians and patients in making decisions about appropriate treatment for specific conditions. Green-top guidelines are concise documents, providing specific practice recommendations on focused areas of clinical practice. The Green-top guidelines are produced under the direction of the Guidelines and Audit Committee of the RCOG.

The Management of Severe Preeclampsia/Eclampsia is a RCOG Green Top guideline number 10a and was published in March 2006. It contains evidence levels and 52 references. The levels of evidence used are as follows:

RCOG evidence grades

A - Requires at least one randomised controlled trial as part of the body of literature of overall good quality and consistency addressing the specific recommendation.

B - Requires availability of well-conducted clinical studies but no randomised clinical trials on the topic of recommendation.

C - Requires evidence from expert committee reports or opinions and/or clinical experience of respected authorities. Indicates absence of directly applicable studies of good quality.

D - Good practice point. Recommended best practice based on the clinical experience of the guideline development group.

Classification of evidence levels

Ia Evidence obtained from meta-analysis of randomised controlled trials.

Ib Evidence obtained from at least one randomised controlled trial.

IIa Evidence obtained from at least one well designed controlled study without randomisation.

IIb Evidence obtained from at least one other type of well-designed quasi-experimental study.

III Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies.

IV Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities.

Royal College of Obstetricians and Gynaecologists UK 2006.  Available from: http://www.rcog.org.uk/files/rcog-corp/uploaded-files/GT10aManagementPreeclampsia2006.pdf (accessed July 2009)

Download preeclampsia guideline (pdf) or quick guide (pdf)

Contents:

• Introduction
• Research questions
• Evidence and Recommendations
• Methods of search and Appraisal
• References
• Download

Introduction

The 3centres Collaboration contracted the Royal Women's Hospital (RWH) Clinical Practice Improvement Unit (CPIU) to conduct a comprehensive search and critical appraisal of publications addressing the topic of "The number and timing of routine antenatal visits", between January 2000 and April 2005, to inform the proposed review of the 2001 3centres Consensus Guidelines on Antenatal Care.

An antenatal visit is defined as an intentional encounter between a pregnant woman and a midwife or doctor to assess and improve maternal and fetal well-being throughout pregnancy and prior to labour. The rationale for the 'traditional' schedule developed in the UK during the 1920s is based on the theory that regular visits with predefined content enable midwives and doctors to detect conditions in mother and baby that may threaten their health. Conditions are then monitored or treated to ensure a safe delivery and better outcomes. The 'traditional' number of antenatal visits is approximately 14, based on early presentation and a schedule of four weekly visits until 28 weeks gestation, then fortnightly visits until 36 weeks gestation, followed by weekly visits until birth. This schedule does not always include additional visits required for new technologies such as routine fetal anomaly screening tests, antenatal classes, social needs assessment or postnatal planning. Over the last twenty years various studies have questioned the traditional schedule for both frequency and content in relation to perinatal outcome, cost- effectiveness and satisfaction with care. The number, timing and content of antenatal visits should be structured to reflect the preferences of the mother, and to optimise accurate diagnosis and management of maternal and fetal complications.

Research questions addressed

1. In low risk pregnant women is a reduced schedule of visits as effective as the traditional schedule of approximately 14 visits in achieving positive perinatal outcomes?
2. In low risk women is a reduced schedule of visits as effective as the traditional schedule in terms of women's satisfaction with care?
3. Is a reduced schedule of visits (<14) as effective in low risk primigravida as in low risk multigravidas in achieving positive perinatal outcomes and satisfaction with care?
4. In low risk women is a reduced schedule of visits (<14) more cost effective than the traditional schedule?

Evidence

It is essential that routine antenatal care delivers effective and appropriate screening, preventive, or treatment interventions. Thus, the number of visits should ensure delivery of these interventions in a timely way during pregnancy, without any clinically important increase in the risk of adverse outcomes2. If reduced antenatal visits are adopted for low risk women, a plan must be in place to direct the practitioner to early and prompt referral for departures from the low risk pathway (22).  

1. In low risk pregnant women is a reduced schedule of visits as effective as the traditional schedule of approximately 14 visits in achieving positive perinatal outcomes?

In low risk pregnant women a reduced schedule of antenatal visits appears to be as effective as the traditional schedule of approximately 14 visits in achieving positive perinatal outcomes. 

In particular, there is no clinical difference when the number of antenatal visits was reduced with respect to preeclampsia, urinary tract infection, post partum anaemia, maternal mortality, antepartum haemorrhage, induction of labour, caesarean section, postpartum haemorrhage, small for gestational age, admission to NICU and low birth weight, (2,3).  

Recommendation (A-B) 

The 3centres Collaboration concurs with the RCOG recommendations of: "A schedule of antenatal appointments should be determined by the function of the appointments. For a woman who is nulliparous with an uncomplicated pregnancy, a schedule of ten appointments should be adequate. For a woman who is parous with an uncomplicated pregnancy, a schedule of seven appointments should be adequate."(1)

"Early in pregnancy, all women should receive appropriate written information about the likely number, timing and content of antenatal appointments associated with different options of care and be given an opportunity to discuss this schedule with their midwife or doctor."(1)

"Each antenatal appointment should be structured and have focused content. Longer appointments are needed early in pregnancy to allow comprehensive assessment and discussion. Wherever possible, appointments should incorporate routine test and investigations to minimize inconvenience to women."(1)

An important caveat in the Australian care setting is that antenatal care must be individualized in particular for groups such as the indigenous community who may be at higher risk of adverse pregnancy outcomes

2. In low risk women is a reduced schedule of visits as effective as the traditional schedule in terms of women's satisfaction with care

Evidence regarding women's satisfaction with care with a reduced schedule of visits is conflicting. In general, satisfaction appears to be reduced, and women in general prefer the traditional number of antenatal visits (2,3,20). However, factors including increased number of children and maternal age >35 years and unfortunate timing of pregnancy may result in a wish for fewer antenatal visits. A desire for more visits was associated with depression, previous miscarriage, previous negative birth experience and in primiparas maternal age 18 <25 years and assisted conception.

Continuity of care has consistently been identified as an important factor for maternal satisfaction with care. In the largest study, women and providers accepted the new antenatal care model generally. (20)

Recommendation (Grade A-B)

Women may be less satisfied with antenatal care when a reduced schedule of visits is implemented. However, the majority of women expressed satisfaction with antenatal care.

Particular attention should be paid to women with a miscarriage or a negative birth experience.

3. Is a reduced schedule of visits (<14) as effective in low risk primigravida as in low risk multigravidas in achieving positive perinatal outcomes and satisfaction with care?

Primiparas were less likely to express a preference than multiparas for the model of antenatal care. Of those who expressed a preference the majority would opt for 'traditional' care. There is limited data comparing perinatal outcomes for primiparas versus multiparas.(21)

Recommendation (Grade B)

Women's preferences regarding antenatal care schedule should be considered when individualizing antenatal care management.

4. In low risk women is a reduced schedule of visits (<14) more cost effective than the traditional schedule?

Evidence regarding cost effectiveness of reduced schedule of visits is conflicting (1,2).

Recommendation (Grade A)

There is limited evidence regarding cost effectiveness of reduced schedule of antenatal visits.

Methods of search and Appraisal

Search strategy

The OVID interface was used to search the following electronic databases:

• MEDLINE: 2000 – May 2005
• CINAHL: 2000 – May 2005
• EBM Reviews: January 2000 – May 2005

Cochrane Database: 2005 Issue 2

Review of article citations and Cochrane Library references for additional citations

• Guidelines developed by specific Colleges of Obstetricians and Gynaecologists were searched including:
  • Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG)
  • Royal College of Obstetricians and Gynaecologists (RCOG), and
  • Society of Obstetricians and Gynaecologists Canada (SOGC).

Guidelines developed by other groups were searched for via the internet, on the United States National Guidelines Clearinghouse.

Search terms

The search was conducted in three sections and included search terms: antenatal, pregnancy, visit, schedule, consultation +outcome, prenatal diagnosis, satisfaction, cost effectiveness, cost/benefit analysis.

Initial search

Two guidelines were retrieved. The AGREE tool was applied by the project team and as a result the first one was included as a key citation.

Royal College of Obstetricians and Gynaecologists (RCOG). Clinical Guideline: Antenatal care: routine care for the healthy pregnant woman1.

Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Routine prenatal care.

In addition to the guidelines, the initial search applied the following inclusion and exclusion criteria to retrieve 138 citations

Key citation selection

All 140 citations identified in the initial search were triaged into those:

• Possibly containing relevant evidence or authoritative opinion (72 citations), and
• Unlikely to contain relevant evidence or authoritative opinion (68 citations). These citations were either too general or not relevant to the topics to be addressed and were not considered further.

The 68 citations were retrieved and further screened to identify those studies with respect to quality of methodology and relevance to Australian obstetric practice. As a result of this exercise 21 articles were classified as key citations, and were subjected to systematic critical appraisal by the CPIU project team and those not meeting the criteria were discarded.

The evidence within these 21 key citations fell into the following levels:

• Level I evidence: 2 publications
• Level II evidence: 3 publications,
• Level III evidence: 6 publications, and
• Level IV evidence: 10 publications.

References

1. Royal College of Obstetricians and Gynaecologists (RCOG). Evidence based guidelines Antenatal care: routine care for the healthy pregnant woman. 2003. (Level IV) (http://www.rcog.org.uk/resources/Publ ic/Antenatal_Care.pdf
2. Villar J, Bergsjo P. Scientific basis for the content of routine antenatal care. Acta Obstetricia et Gynecologica Scandinavia 1997;76:1-14. (Level IV)
3. Carroli G, Villar J, Piaggio G, Khan- Neelofur D, Gulmezoglu M, Mugford M, et al. WHO systematic review of randomised controlled trials of routine antenatal care. Lancet 2001;357(9268):1565-70. (Level I)
4. Sikorski J,Wilson J, Clement S, Das S, Smeeton N. A randomised controlled trial comparing two schedules of antenatal visits: the antenatal care project. BMJ 1996;312:546-553. (Level II)
5. Villar J, Carroli G, Khan-Neelofur D, Piaggio G, Gulmezoglu M. Patterns of routine antenatal care for low-risk pregnancy. Cochrane Database of Systematic Reviews 2001(4):CD000934. (Level I)
6. Jewell D, Sharp D, Sanders J and Peters TJ. A randomised controlled trial of flexibility in routine antenatal care. BJOG 2000;107:1241-1247. (Level II)
7. Villar J, Ba'aqeel H, Piaggio G, Lumbiganon P, Miguel Belizan J, Farnot U, et al. WHO antenatal care randomised trial for the evaluation of a new model of routine antenatal care. Lancet 2001;357(9268):1551-64. (Level II)
8. Villar J, Khan-Neelofur D. Patterns of routine antenatal care for low risk pregnancy. (CochraneReview). , The Cochrane Library Issue 2, 2000 Oxford: Update Software. (Level I)
9. Hunt JM, Lumley J. Are recommendations about routine antenatal care in Australia consistent and evidence-based? Medical Journal of Australia 2002;176(6):255-9. (Level IV)
10. Carolli G, Villar J, Piaggio G, Gulmezoglu M, Mugford M, Lumbiganon P, Farnot U, Bersgjo P for the WHO Antenatal Care Trial Research Group WHO systematic review of randomised controlledtrials of routine antenatal care. Lancet 2001;357:1565-1570. (Level I)
11. Gerein N, Mayhew S, Lubben M. A framework for a new approach to antenatal care. International Journal of Gynaecology & Obstetrics 2003;80(2):175-82. (Level IV)
12. Villar J, Ba'aqeel H, Piaggio G, Lumbiganon P, Belizan JM, Farnot U, Al- Mazrou Y, Carolli G, PinolA, Donner A, Langer A, Nigenda G, Mugford M, Fox- Rushby J, Hutton G, Bergsjo P, Bakketeig L, Berendes H, for the WHO Antenatal Care Trial group. WHO antenatal care randomised trial forthe valuation of a new model of routine antenatal care. Lancet 2001;357:1551-1570. (Level II)
13. Candy B, Clement S, Sikorski J, Wilson J. Antenatal visits. Practising Midwife 2000;3(3):21-4. (Level IV)
14. Clement S, Sikorski J, Wilson J, Das S, Smeeton N. Women's satisfaction with traditional and reduced antenatal visit schedules. Midwifery 1996;12:120-128. (Level II)
15. Walker DS, McCully L, Vest V. Evidence- based prenatal care visits: when less is more. Journal of Midwifery & Women's Health 2001;46(3):146-51. (Level IV)
16. Jewell D, Sanders J, Sharp D. The views and anticipated needs of women in early pregnancy. BJOG 2000;107:1237-1240. (Level IV)
17. Waters D, Picone D, Cooke H, Dyer K, Brodie P, Middleton S. Midwifery-led care: finding evidence for an antenatal model. Australian Midwifery; 2004; 17(2): 16-20. (Level IV)
18. Clement S, Sikorski J, Wilson J, Das S. Planning antenatal services to met women's psychological needs. Brit J of Midwifery 1997;5(5):298-305. (Level IV)
19. Homer CS, Davis GK, Brodie PM, Sheehan A, Barclay LM, Wills J, et al. Collaboration in maternity care: a randomised controlled trial comparing community-based continuity of care with standard hospital care. BJOG: an International Journal of Obstetrics & Gynaecology 2001;108(1):16-22. (Level II)
20. Lumley J. What do women really want? Satisfaction with care in pregnancy, birth and the postnatal hospital stay. A summary of the current evidence Unpublished report commissioned by the Royal Women's Hospital, Melbourne from the Centre for the Study of Mother's and Children's Health, La Trobe University, Melbourne 2000. (Level IV)
21. Tasnim N, Mahmud G, Arif MS. Impact of reduced prenatal visit frequency on obstetric outcome in low-risk mothers. Jcpsp, Journal of the College of Physicians & Surgeons - Pakistan 2005;15(1):26-9. (Level III-2)
22. Tough SC, Newburn-Cook CV, White DE, Fraser-Lee NJ, Faber AJ, Frick C, et al. Do maternal characteristics and past pregnancy experiences predict preterm delivery among women aged 20 to 34? Journal of Obstetrics & Gynaecology Canada: JOGC 2003;25(8):656-66. (Level III-2)
23. Petrou S, Kupek E, Vause S, Maresh M. Antenatal visits and adverse perinatal outcomes: results from a British population-based study. European Journal of Obstetrics, Gynecology, & Reproductive Biology 2003;106(1):40-9. (Level IV)
24. Petrou S, Kupek E, Vause S, Maresh M. Clinical, provider and sociodemographic determinants of the number of antenatal visits in England and Wales. Social Science & Medicine 2001;52(7):1123-34. (Level IV)
25. Jewell D, Sharp D, Sanders J, Peters TJ. A randomised controlled trial of flexibility in routine antenatal care.[see comment]. BJOG: an International Journal of Obstetrics & Gynaecology 2000;107(10):1241-7. (Level II)
26. Gaff-Smith M. Antenatal attendance by Aboriginal women. Birth Issues; 9(4):118-22 2000. (Level IV)
27. Hildingsson I, Radestad I, Waldenstrom U. Number of antenatal visits and women's opinion. Acta Obstetricia et Gynecologica Scandinavica 2005;84(3):248-54. (Level III-2)
28. Hildingsson I, Waldenstrom U, Radestad I. Women's expectations on antenatal care as assessed in early pregnancy: number of visits, continuity of caregiver and general content. Acta Obstetricia et Gynecologica Scandinavica 2002;81(2):118-25. (Level III-2)
29. Walker DS, Day S, Diroff C, Lirette H, McCully L, Mooney-Hescott C, et al. Reduced frequency prenatal visits in midwifery practice: attitudes and use.[see comment]. Journal of Midwifery & Women's Health 2002;47(4):269-77. (Level IV)
30. Langer A, Villar J, Romero M, Nigenda G, Piaggio G, Kuchaisit C, et al. Are women and providers satisfied with antenatal care? Views on a standard and a simplified evidence-based model of care in four developing countries. BMC Womens Health 2002;2(1):7. (Level III- 2)
31. Jewell D, Sanders J, Sharp D. The views and anticipated needs of women in early pregnancy. BJOG: an International Journal of Obstetrics & Gynaecology 2000;107(10):1237-40. (Level III-2)
32. Greer I. Pre-eclampsia matters. BMJ 2005:330:549-50. (Referenced in text but not a key citation)

Note: References with an "a" are original 2001 references

Download guideline (pdf) or Literature Review (pdf 451 KB)

Evidence

Following the Victorian Birthing Services Review in 1990 the federal government recommended the development of antenatal care models that allowed greater:

• Continuity of care.
• Choice of GP or midwife carer.
• Ease of access to care.
• Involvement of women in decisions about care.
• Socially and culturally appropriate care.
• Shorter waiting times for antenatal appointments. 
• An expanded role for midwives .

Since 1990 the Three Centres in Victoria have introduced new models of midwifery care, satellite clinics and expanded GP shared care. Women enrolled in midwifery or shared care models are required to see a hospital doctor between one and four times during pregnancy (with these visits usually scheduled at the first or second antenatal visit, and at 26, 36 and 41 weeks). The frequency of obstetric visits varies between hospitals and between models of care within hospitals. In 1999 the Review of Shared Obstetric Care in Victoria identified women in this State:

• Have difficulty accessing information about the range of options and models of care available.
• Do not have information about models of care routinely distributed.
• Find one of the barriers to women accessing information about the range of options may be professional rivalries and sensitivities.
• Have difficulty obtaining accurate information about the costs they are likely to incur for investigations and appointments in various models of care (2).

Concerns expressed about women's safety with 'new' models of care has meant that innovations involving midwifery-led care are generally introduced as a trial or pilot study and regularly reviewed. The net result is a growing body of high level Australian evidence addressing+ midwifery-led antenatal care in terms of safety, continuity, and satisfaction with care compared to standard care++. Unfortunately, there is not the same body of Australian evidence addressing GP-led care or combined care compared to standard care, though UK and Scottish trials establish the safety of GP 3 shared care . Evidence supports the conclusion that team midwifery, community-based collaborative care, shared care and birth centre care for low risk women integrated within existing services are clinically effective (4-10).Team midwifery and collaborative care are likely to be safe and very satisfactory for women with moderate to high risk factors, though pooled data is required to properly assess effects on perinatal outcome (10).

In a randomised trial involving 1,000 women at Monash Medical Centre, Biro et al (Level II) compared team midwifery with heterogeneous 'standard' care for both high and low risk women. Standard care involved many different staff, whereas team midwifery emphasised continuity of carer. Data showed that 80 per cent of team midwifery patients were attended during labour by a midwife known to them compared with 0.3 per cent of standard care patients.

Augmentation of labour, use of pethidine and epidurals, fetal monitoring and episiotomy rates were significantly reduced in the team midwifery group. Perineal tears were greater in number but more were unsutured. While there were fewer pre-term babies (2.4 per cent or 11 babies versus six per cent or 26 babies, OR 0.39) admitted to SCN, eight babies from the midwifery group were admitted for growth restriction. Other neonatal measures showed no differences. Five perinatal deaths occurred in the team care group and four in standard care (4). A randomised trial of team midwifery involving 1,000 women at the Royal Women's Hospital found similar results. Team midwife care was associated with increased satisfaction and differences between groups were most notable for antenatal care. There were no differences between team midwife care and standard care in medical interventions or in women's emotional  well-being as measured two months after the birth (9).

Homer, Davis and Brodie, et al. (Level II) randomised 1,089 women into 'standard' hospital based care at St George Hospital in Sydney and community-based collaborative care involving a small team of midwives and hospital obstetricians. The study emphasis was on continuity. They found a significant reduction in Caesarean rates, their primary outcome of interest (OR 0.6 CI 0.4-0.9). There were no other significant differences in labour or birth events or neonatal problems. The study was too small to detect differences in perinatal mortality. The authors conclude that team midwifery can reduce Caesarean rates for both low and high risk women and that their rate of perinatal mortality is comparable with other Australian data (7).

Waldenstrom and Turnbull analysed data from seven trials (n=9,148) not including the three above, comparing continuity of midwifery-led care to standard maternity care on an intention-to-treat basis found less use of obstetric interventions in the midwifery led groups. Caesarean section rates did not differ statistically. There was a significantly higher rate of perineal tears in the pooled midwifery groups, but no significant differences in maternal deaths, maternal complications or proportion of infants with Apgar score <7 at five minutes. Admission rates to NICU or special care baby units were also similar between the standard and intervention groups. However, the difference in perinatal deaths bordering on statistical significance (OR 1.60; 95 per cent CI 0.99 to 2.59) (10).

The authors called for further trials to elucidate whether this finding was true or false. Pooled data that includes the three Australian trials previously mentioned (n=3,089) is awaiting publication.

In Australia concerns over the safety of women in midwifery- or GP-led models of care has also led to the widespread practice of routine visits with an obstetrician at designated times. While there is no question women should see an obstetrician when complications are indicated, the value of routine obstetric visits for low risk women is debated. A Scottish multi-centre randomised trial involving 1,765 women compared routine antenatal care for low risk women by GPs and midwives in community settings (providing a care plan and protocols for managing complications) with obstetrician-led shared care. The authors cite five previous UK studies that found improvements in the community model for access to care, uptake of care, improved continuity of care and pregnancy outcomes at least as good as hospital obstetric care. In this trial women saw a specialist according to their individual needs, and not at a predefined routine visit. This study found similar gains, and that multiparous women in the midwifery and GP group had slightly fewer visits (Mean 10.6 visits versus 11.6 visits, CI=0.95). There was a similar level of satisfaction between intervention and control groups, but the significant difference lay in intervention participants getting on 'very well' with their main carer and preferring to see the same person each time. The results of the study indicate that women initially assessed at low risk of pregnancy complications may have little or no benefit from routine specialist antenatal visits (3).

Waldenstrom and Nilson's randomised controlled study compared birth centre care, where low risk women were referred to see a doctor for a medical indication only, with standard maternity care. Birth centre women made fewer antenatal visits, both to midwives and doctors, and had fewer antenatal tests. Both groups reported antenatal complications to the same level. There was no statistical difference in antenatal hospital admissions. There was less medical intervention used in the intra-partum and postnatal periods. Twenty per cent of women in both groups saw a doctor during the first two months following delivery for similar health problems. There was no statistical difference in hospital re-admissions. The authors concluded that birth centre care is effective in identifying significant maternal complications and as safe as standard maternity care for women (11).

Measuring satisfaction with antenatal care is difficult, not only as models of care are heterogeneous and measurement of satisfaction contentious but because the continuity of care characteristic of midwifery and GP-led models confounds the issue of satisfaction (7-10,12,13). A Cochrane review of continuity of antenatal caregivers concluded that women who experienced continuity of care were more likely to be more satisfied with their level of care and caregivers, (12) though a Swedish trial suggested that continuity of carer is less important at a birth centre (11). Surveys conducted with recent mothers (SRM) in Victoria during 1989, 1993 and 1999 provide Level IV evidence concerning satisfaction with care. Results underscore the need for women to be informed of their options regarding pregnancy care and the implications of each option in terms of cost, continuity and the transition from hospital to home. The 1989 SRM indicated that women attending public hospital clinics (standard care) were the least satisfied with antenatal care, and those attending private obstetricians were the most satisfied, with GP care intermediate. The follow-up survey in 1993 indicated women were most likely to be satisfied when antenatal care was provided by a private obstetrician, private GP or birth centre. Women in public GP care, who were largely from rural areas and more likely to have received 'quasi-private' care with their own GP, were an intermediately satisfied group. Fewer than half the women who attended a public clinic viewed their care as very good, and the expansion of shared care did not appear to have reduced waiting times and rushed appointments at public clinics. Women participating in shared care did not appear to find it a better option than public clinic care, though shared care programs vary considerably and some programs are likely to work better than others (14). Satisfaction with antenatal care is generally low for women born outside Australia (even after taking account of their risk status and model of care), from low socioeconomic backgrounds and/or from a non-English speaking background. Local studies indicate more attention should to be given to reducing barriers to effective communication (15-17). The 1999 survey results are unpublished at the time of writing, but data indicate that private obstetric care rates as most satisfactory for antenatal care, followed by birth centre care and midwifery clinics. Public clinics were rated the least satisfactory for antenatal care.

The factors that increase satisfaction with pregnancy care are consistent across different countries and time periods. Continuity of care is strongly associated with satisfaction (12). Level III and IV evidence indicates women value staff who:

• Exhibit qualities of courtesy, kindness, support, respect women as individuals and recognise individual needs.
• Offer information, provide clear explanations and facilitate questions.

Women are less satisfied where there is a lack of information about options for antenatal care, long waits for antenatal visits or rushed check-ups.

Differences in satisfaction with different models of care are explicable in terms of the extent to which the above needs are satisfied within each model of care. Consistent information, a sense of control, involvement in decision-making, and confidence in clinical care has also been associated with increased satisfaction with pregnancy care in an Australian population as well as in other countries (18-20). A descriptive study of 200 Brisbane women enrolled in shared and standard care found that women who carry their own antenatal record felt more in control, had less difficultly talking to their doctor and rated satisfaction with care significantly higher than women in the standard care group (21). While a reduced schedule of antenatal visits was associated with decreased satisfaction with care (or increased anxiety) in two UK trials (22,23), the researchers were unsure if this would hold over time and could not readily identify the women likely to be dissatisfied with a reduced schedule of visits (22). The researchers concluded this finding indicated the importance of talking to women individually and, as far as possible, tailoring care to individual preferences (22,23).

The term 'continuity of care' may refer to any of the following situations:

a) Women see the same care providers across different stages of antenatal, intrapartum and postnatal care.

b) Women have one-to-one care from a single practitioner during pregnancy and labour.

c) Women are cared for by a small number of care providers working together as a team with shared philosophy and guidelines for practice.

Midwifery-led care refers to models where midwives provide all or most antenatal care. These may or may not emphasise continuity of care. Midwifery led models of care include midwives clinics, team midwifery and birth centre care.

'Standard or conventional care' refers to the hospital antenatal clinics in which women see the doctor or midwife that is available at the time of their appointment. These doctors and midwives may be in training. Women may see similar care providers each visit if the particular hospital operates in this way. Likewise, women may be allocated to a particular unit or team. In some hospitals accredited community GPs provide some of the care.

GP-led care refers to models where GPs provide all or most antenatal care either in private rooms or as part of hospital clinics. These models may or may not emphasise continuity of care.

Methods of Search and Appraisal

I. Search on Defined Questions (March 2001)

A research team from the Department of Perinatal Medicine at the Royal Women's Hospital used the OVID interface to search Premedline and Medline, CINAHL, Best Evidence (Jan 1990 to Mar 2001) and the

Cochrane Database (2001, Issue 1) to answer:

1. How do options of Midwifery led care GP-led care (shared care) Obstetrician led care Multidisciplinary/team/collaborative care For women assessed as low risk at their first antenatal visit compare to conventional outpatient care, in terms of: Obstetric interventions Maternal and neonatal morbidity Perinatal mortality Satisfaction with care, and Cost-effectiveness?
2. Do routine visits to an obstetrician (at 14, 26 and 36 weeks gestation), compared with discretionary visits, for women initially assessed as low risk of obstetric complications, offer clinical benefits or increase satisfaction with care?

The team searched the bibliographies from articles retrieved for additional citations and hand-searched relevant, non-peer reviewed literature. The search retrieved 172 citations, from which 41 key citations were identified. These included three Level I systematic reviews, 16 Level II, 13 Level III 2, one Level III-3 and seven Level IV studies/documents. The coordinator searched grey literature and journals for additional evidence published between April and August 2001.

References

1. Final Report of the Ministerial Review of Birthing Services in Victoria. Having a Baby in Victoria. Health Department, Victoria 1990. Level IV
2. Brown S, Dawson W, Gunn J, McNair R. Review of Shared Obstetric Care: Summary Report. Centre for the Study of Mother's and Children's Health, La Trobe University, Carlton 1999. Level IV
3. Tucker JS, Hall MH, Howie PW, et al. Should obstetricians see women with normal pregnancies? A multicentre randomised controlled trial of routine antenatal care by general practitioners and midwives compared with shared care led by obstetricians [see comments]. BMJ 1996;312(7030):554-9. Level II
4. Biró MA, Waldenström U, Pannifex JH. Team midwifery care in a tertiary level obstetric service: a randomised controlled trial [including commentary by Kaufman K].Birth 2000;27(3):168-76. Level II
5. Cunningham JD. Experiences of Australian mothers who gave birth either at home, at a birth centre, or in hospital labour wards. Social Science and Medicine 1993;36(4):475-83. Level III 2
6. Giles W, Collins J, Ong F, MacDonald R. Antenatal care of low risk obstetric patients by midwives. A randomised controlled trial [see comments]. MJA 1992;157(3):158-61. Level II
7. Homer CS, Davis GK, Brodie PM, Sheehan A, Barclay LM, Wills J, Chapman MG. Collaboration in maternity care: a randomised controlled trial comparing community-based continuity of care w i t h s t a n d a r d h o s p i t a l c a r e . B J O G 2001;108(1):16-22. Level II
8. Rowley MJ, Hensley MJ, Brinsmead MW, Wlodarczyk JH. Continuity of care by a midwife team versus routine care during pregnancy and birth: a randomised trial. MJA 1995;163(6):289- 93. Level II
9. Waldenström U, Brown S, McLachlan H, Forster D, Brennecke S. Does team midwife care increase satisfaction with antenatal, intrapartum, and postpartum care? A randomised controlled trial. [including commentary by Kaufman K] Birth 2000;27(3):156-67,174-6. Level II
10. Waldenstrom U, Turnbull D. A systematic review comparing continuity of midwifery care with standard maternity services. [Review] [32 refs]. BJOG 1998;105(11):1160-70. Level I
11. Waldenstrom U, Nilsson C. A randomized controlled study of birth center care versus standard maternity care: effects on women's health.Birth 1997;24:17-26. Level II
12. Hodnett ED. Continuity of caregivers for care during pregnancy and childbirth. [Review] [2 refs]. Cochrane Database of Systematic Reviews [computer file] (2):CD000062 2000. Level I
13. Waldenstrom U. Continuity of carer and satisfaction. Midwifery 1998;14(4):207-13. Level IV
14. Laslett AM, Brown S, Lumley J. (1997) Women's views of different models of antenatal care in Victoria, Australia. Birth 24(2):81-9. Level III 2
15. Rice PL, Naksook C. The experience of pregnancy, labour and birth of Thai women in Australia. (45 ref).Midwifery 1998;14(2):74-84. Level IV
16. Small R, Lumley J, Yelland J, Rice PL. Shared antenatal care fails to rate well with women of non- E n g l i s h s p e a k i n g b a c k g r o u n d s . M J A 1998;168(1):15-8. Level III 2
17. Small R, Rice PL, Yelland J, Lumley J. Mothers in a new country: the role of culture and communication in Vietnamese, Turkish and Filipino women's experiences of giving birth in Australia. Women and Health 1999;28:77-101. Level III 2
18. Lumley J. What do women really want? Satisfaction with care in pregnancy, birth and the postnatal hospital stay. A summary of the current evidence. Unpublished report commissioned by the Royal Women's Hospital, Melbourne from the Centre for the Study of Mother's and Children's Health, La Trobe University, Melbourne 2000. Level IV
19. Hundley V, Rennie AM, Fitzmaurice A, Graham W, Teijlingen EV, Penney G. A national survey of women's views of their maternity care in Scotland. Midwifery 2000;16(4):303-313. Level III 2
20. Garcia J, Redshaw M, Fitzsimons B, Keene J. First Class Delivery: A national survey of women's views of maternity care. Audit Commission, London 1998. Level IV 21.Webster J, Forbes K, Foster S, Thomas I, Griffin A, Timms H. Sharing antenatal care: client satisfaction and use of the 'patient-held record'. ANZJOG 1996;36(1):11-4. Level III 2
21. Clement S, Sikorski J, Wilson J, Das S, Smeeton N. Women's satisfaction with traditional and reduced a n t e n a t a l v i s i t s c h e d u l e s . M i d w i f e r y 1996;12(3):120-8. Level II
22. Jewell D, Sharp D, Sanders J and Peters TJ. A randomised controlled trial of flexibility in routine antenatal care. BJOG 2000;107:1241-1247. Level II