WHA Consensus Statement on induction of labour for first time mothers, November 2016
Consensus Statement on:
Best practice care for first time mothers:
Induction of Labour
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
Introduction .................................................................................................................................................. 3
Rationale................................................................................................................................................... 3
Scope of this Consensus Statement......................................................................................................... 4
Levels of evidence .................................................................................................................................... 4
How this draft Consensus Statement has been developed ...................................................................... 4
Acknowledgements .................................................................................................................................. 5
Section 1: Supporting women to make an informed decision about induction ............................................. 6
Discussing induction of labour with women.............................................................................................. 7
Section 2: Induction of labour for women giving birth for the first time ...................................................... 10
Indications for which there is strong evidence of benefit from induction of labour ................................. 10
Indications for which there is currently no strong evidence of benefit from induction of labour .............. 10
Part A: Which women should be offered induction and when? .................................................................. 12
2.1 Induction of labour for women at or beyond term ............................................................................. 12
2.2 Induction of labour for improving birth outcomes for women with gestational hypertension or preeclampsia ............................................................................................................................................... 13
2.3 Preterm premature rupture of the membranes .................................................................................. 14
2.4 Term premature (prelabour) rupture of membranes .......................................................................... 15
2.5 Suspected intrauterine growth restriction at term ............................................................................. 16
2.6 Suspected fetal macrosomia at term ................................................................................................ 17
Part B: What methods of induction are utilised? ........................................................................................ 19
Part C: Where should cervical ripening take place? ................................................................................... 20
Reference List ............................................................................................................................................ 21
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
Introduction
This draft consensus statement is being developed by members of Women’s Healthcare Australasia (WHA).
There are currently 90 maternity services across Australia that are WHA members; including the majority of
tertiary maternity services and a large number of metropolitan, regional and rural maternity units.
Collectively, WHA members care for more than 140,000 women giving birth each year, or 60% of all public
births (WHA, 2015).
WHA benchmarking data demonstrates considerable variation in practice across members in relation to care
of first time mothers. Some variation would be expected, given the different patient, pregnancy and facility
characteristics. However, members of WHA’s Special Interest Group on Safety & Quality in Maternity Care
are committed to enhancing the experience and outcomes for first time mothers and their newborns by
reducing unwarranted variation.
With a focus on level 1 evidence, the members’ goal is to strengthen the consistency with which evidence
based practice is occurring across the WHA community of services in relation to labour and birth care for
women having their first baby. The development of a series of consensus statements on best practice care
for first time mothers was agreed to by members as a key strategy to help achieve this goal. The focus of
this consensus statement is on Induction of Labour. It seeks to highlight those aspects of care where there
is high level evidence to support decisions about best practice care for women being offered induction of
labour. Thus there can be a high degree of confidence in the recommendations.
This consensus statement does not aim to be comprehensive of all aspects of clinical care for women whose
labour are induced. It is respected that each member service has its own clinical guidelines, whether at the
jurisdictional or service level, that take into account the characteristics of women attending that service and
the resources and capabilities of the hospital. This document is intended as a guide to support collaboration
over time among member services through the sharing of information, strategies and know-how in their
respective efforts to translate research evidence into clinical practice.
Rationale
This consensus statement has been developed in response to unexplained variation, particularly in rates of
induction of labour (IOL) and caesarean section (CS) for first time healthy mothers. WHA members share
data on rates of intervention in labour and birth for all women, as well as for an agreed cohort of selected
primiparas, i.e. those women aged between 20-34 years, with a singleton pregnancy, cephalic presentation
born at term (37.0 to 41.0 weeks). The separate identification of selected primiparas is intended to provide
a method of pre-risk adjustment control for the differing complexity of casemix at different hospitals.
Outcomes from WHA’s 2015/16 Benchmarking Maternity Care program show the mean rate of induction of
labour for selected primiparas was 33.5%. The range for tertiary centres (Level 6) was between 21.3% to
51.6%, and Level 1-5 hospitals ranged from 15.8% to 48.7%. During the same time period, the caesarean
section rate for selected primiparas demonstrated a mean of 22.43% across the WHA membership, with a
range of 15.5% to 27.9% for tertiary centres, and 11% to 31.7% for Level 1-5 hospitals.
Furthermore, WHA benchmarking has confirmed a sustained upward trend in rates of induction among WHA
member hospitals over the past 5 years. Rates of induction of selected primiparas have risen in Level 1-5
services from 23.4% to 31.1%, and in Level 6 services from 29.9% to 37.5%. Rates of caesarean section
for selected primiparas have stabilised over the same time period at an average of around 23% for both
Level 1-5 and Level 6 services.
In light of both unexplained variation and a confirmed trend of increasing rates of induction of labour in a
healthy cohort of women, WHA members resolved at the Safety & Quality Forum in November 2015 to create
this consensus statement. This statement is not intended to mitigate the need for clinical judgement or to
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
dictate to women what decision they should make when being offered induction. It is designed to support
evidence based decision making that necessarily involves clinical judgement and the wishes of each woman.
Scope of this Consensus Statement
This document includes consideration of induction of labour for women giving birth for the first time. In
particular it covers
-
Supporting women to make an informed decision about induction
Indications for induction
Gestational age at time of induction
Methods of induction preparation
Location for induction preparation.
Levels of evidence1
This document references Level I and II evidence. The most appropriate study design to answer clinical
questions regarding interventions is Level II evidence i.e. a randomised controlled trial. Level I studies are
systematic reviews of the appropriate Level II studies in each case. Study designs that are progressively
less robust are rated as Level III or IV.
How this draft Consensus Statement has been developed
More than 80 individuals representing over 50 WHA member hospitals met at the end of 2014 and 2015 to
discuss current practice and contemporary research findings in relation to IOL and CS for primiparous
women. A first draft of this consensus statement was circulated to members in March 2016, based on the
November 2015 meeting. A second draft was circulated mid-2016, with comments sought from all WHA
member hospitals. Consultations with members have been taking place via email, face to face meetings
between WHA and members, and phone calls between June and September 2016. A third round of
consultation occurred up until late October 2016.
Feedback from members on the first draft of this statement identified a concern that the statement may be
likely to contribute to further rises in the rates of induction. Members requested that the document be
restructured to include a section on how to support women to make informed decisions about induction of
their labour, and to include a clear list of indicators currently being used to trigger an offer of induction for
which there is little or no evidence of benefit. These changes were incorporated into the second draft, with
the section discussing evidence now appearing at the end of the document.
Feedback received on the second draft highlighted updated and new evidence that has now been
incorporated into the document. The lists of indications where induction is supported, not supported, or
based on individual circumstances have been refined and updated for clarity.
This consensus statement represents a first step towards identifying those elements on which there are
strong and clear indications of best practice care, and helping members to evaluate the extent to which their
own services provide care consistent with that evidence. The process of developing this consensus
statement identified a number of gaps and inconsistencies in the research, and raised a number of other
issues around which there needed to be further engagement with WHA members. A program of action
around those issues was developed.
The WHA Board was particularly keen that all members engage with the process of finalising this document.
While there may remain areas on which WHA members agree to disagree, it is hoped that this consensus
statement will have value as a credible and evidence based guide to contemporary best practice care.
1
NHMRC additional levels of evidence and grades for recommendations for developers of guidelines. Available at
https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
Acknowledgements
WHA wishes to acknowledge and thank all individuals and health services that had input to the development
and refining of this consensus statement. The time and expertise generously shared by members has been
critical to the creation of this resource.
The WHA Board would also like to note particular thanks to the following individuals and health services for
their detailed and considered input to the development of this document:
Prof Michael Nicholl
WHA President, and
Clinical Director, Division of Women's Children's & Family Health
Royal North Shore Hospital
A/Prof Anne Sneddon
WHA Vice-President
Gold Coast University Hospital
Ballarat Health Services, VIC
Centenary Hospital for Women and Children, ACT
WA Country Health Service, WA
Eastern Health, VIC
Gold Coast University Hospital, QLD
Ipswich Hospital, QLD
Mater Mothers Hospital, QLD
Royal Hospital for Women, NSW
Royal North Shore Hospital, NSW
Sunshine Hospital, VIC
Townsville Hospital, QLD
Heather Artuso,
Member Liaison Manager, WHA
Barb Vernon,
CEO, WHA
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
Section 1: Supporting women to make an informed decision about induction
WHA members recognise the need to work with women in order to facilitate informed decision making.
Within the National Safety and Quality Health Service (NSQHS) Standards 2 , Standard 2 focusses on
Partnering with Consumers. Action 2.7.1 of Standard 2 specifically requires that ‘The community and
consumers are provided with information that is meaningful and relevant on the organisation’s safety and
quality performance’. Aligned with this action members have identified the need to:

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Provide consistent, meaningful and timely information to enable informed decision making
Provide information on all options available to women
Make information available through a variety of sources including face-to-face, written, and
electronic, utilising technology where appropriate.
Communicate information using both the language and learning style that is appropriate for the
individual woman
Provide information, group learning, or peer support opportunities for women relating to common
conditions and interventions such as induction of labour
Ensure appropriate time is taken to discuss information with women and to provide time to reflect
on such information with family and other support people
Use positive language in the information provided to women, and
Respect women as decision-makers about their own care.
In Australia, 27.6% of women giving birth had their labour induced during 2013; the rate for women giving
birth for the first time was higher at 33.9% (AIHW, 2015). According to the World Health Organization (WHO),
induction of labour should be considered when “ the risk–benefit analysis indicates that delivering the baby
is a safer option for the baby, the mother, or both, rather than continuing the pregnancy, and when there are
no clear indications for caesarean section and no contraindications for vaginal delivery.” (WHO, 2011) Given
the desired outcome of a medically indicated induction is to achieve a health mother and baby via a vaginal
birth, it is important to look at the evidence that supports decision making around induction.
Some research suggests labour induction can increase the risk of instrumental birth, uterine
hyperstimulation and/or rupture, and caesarean section (SOGC, 2013). Recent research has shown reduced
rates of caesarean section for women who had their labour induced (Mishanina, et al., 2014; Wood, Cooper,
& Ross, 2014). However, these findings do not differentiate between women giving birth for the first time
and women who have given birth previously. When looking only at first time mothers, there are studies that
suggest primiparous women undergoing induction of labour are at an increased risk of caesarean section
delivery (Davey & King, 2016; Ehrenthal, Jiang, & Strobino, 2010; Selo-Ojeme, et al., 2011; Patterson,
Roberts, Ford, & Morris, 2011), although it must be noted that these papers are retrospective cohorts, where
the comparator to induction is spontaneous labour as opposed to expectant management.
When studies compare induction with expectant management rather than spontaneous labour, there is
evidence that induction may be associated with a decreased risk of caesarean section. In a retrospective
study of over 100,000 births in the US, the caesarean section rate was found to be lowest in the spontaneous
labour group at each gestational age except 39 weeks, however they did find improved neonatal outcomes
for women undergoing elective induction (Bailit, Gregory, Reddy, Gonzalez-Quintero, & Hibbard, 2010).
In similar large analyses using population datasets, Darney, et al. (2010), Stock, et al. (2012) and Gibson, et
al. (2014) compared non-medically indicated induction after 37 weeks to expectant management for women
who delivered in the next week or beyond, and reported that the caesarean section rate did not increase.
Randomised controlled trials by Nielson, et al. (2005), Hannah, et al. (1996), Koopmans, et al. (2009) and
Amano, et al. (1999) found that induction was not associated with increased caesarean section when
compared to expectant management.
2
http://www.safetyandquality.gov.au/our-work/accreditation-and-the-nsqhs-standards/
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
In an ideal world, pregnant women would experience no complications, and would go into labour
spontaneously. In reality however, there are many and numerous complications of pregnancy that women
encounter and labour and birth is necessarily induced to improve both maternal and neonatal mortality and
morbidity. As clinicians, it is therefore imperative that indications for induction are identified and acted upon
according to each woman’s individual circumstances, while also avoiding unnecessary inductions. The role
of this document is to assist clinicians in their decision making, and to support conversations with women
around induction, while trying to reduce variation in practice.
Discussing induction of labour with women
The World Health Organization (WHO) states that: induction of labour should be performed only when there
is a clear medical indication for it and the expected benefits outweigh its potential harms (WHO, 2011, p.4).
Therefore, when discussing induction of labour with women it is important to ensure discussion takes place
on the following points (NICE, 2008):
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The reason induction is being offered, and the risks of not being induced
Risks and benefits associated with induction and with different induction methods
Alternatives to induction
Risks and benefits associated with alternative options, and
When, where and how the induction would be carried out if the woman consents to an induction of
her labour.
Reasons for induction are discussed later in this consensus statement, and are varied. Clinicians are
encouraged to utilise current evidence and clinical judgment when offering induction of labour to women. It
of course goes without saying that women must be enabled and supported to make an informed choice in
relation to the management of their pregnancy.
To enable women to make an informed choice, clinicians must provide information that is culturally
appropriate and culturally safe to women and their support network (Australian Health Ministers’ Advisory
Council, 2014). Further consideration should also be given to providing women and their supports sufficient
time to make a truly informed decision. In some instances it is recognised that a decision will need to be
made quickly, however most women should be given time to consider their options, and to return with any
additional questions.
Ideally women and their supports would be given 24-48 hours to consider their decision, unless this would
expose women and their babies to unnecessary risk. The NICE guidelines (2008) recommend that when a
woman reaches 38 weeks gestation a discussion should take place in relation to the risks associated with
prolonged pregnancy and when induction would be offered, should labour not commence spontaneously.
This supports the notion of giving women time to digest the information provided, and to make an informed
choice that is not rushed.
When discussing risk with women, clinicians should be careful to use absolute risk, as opposed to relative
risk. For example, a relative risk of 1.3 or a 30% increase does not contextually explain the real risk for the
woman if the absolute risk is around 1:1,000 or less. Pictorial diagrams that show the number of women
with a particular outcome amongst 10 or 100 women may be more understandable than an expression in
numbers. It may be appropriate to discuss risk in more ways than one which may include the number needed
to treat, or “if 100 women like you do this, then 3 out of those women will have a complication such as this”.
Obtaining consent for induction of labour should be no different from obtaining consent for any procedure
or treatment in medicine. The issues of valid consent, capacity to give consent, and length of time of validity
of consent are all relevant in this context. Health professionals should also take the initiative in organising
for an accredited health interpreter wherever necessary to ensure effective communication and to aid in
informed decision making. It is not the aim of this document to revisit these principles, except to reiterate
that it is essential that women’s right to make a decision about whether or not to accept an offer of induction
is respected.
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
NICE have also produced a list of “do not” recommendations. The entire list is available (NICE, 2008) and
some may be considered open to further debate. This list does give a base for further development at a local
level for service provision however. For example, clinical practice in the UK is more preferentially based in
the use of prostaglandins for induction of labour (as opposed to cervical ripening), which may not translate
to current Australian clinical practice. Given the increase in interest and study of using mechanical methods
for induction of labour, including in the outpatient setting, this may also spark some debate. There are
however, some correlates:
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Induction of labour should not routinely be offered on maternal request alone. However, under
exceptional circumstances (for example, if the woman’s partner is soon to be posted abroad with the
armed forces), maternal request for an induction may be considered at or after 40 weeks
Induction of labour to avoid a birth unattended by healthcare professionals should not be routinely
offered to women with a history of precipitate labour
In the absence of any other indications, induction of labour should not be carried out simply because
a healthcare professional suspects (i.e. without U/S confirmation) a baby is large for gestational age
(macrosomic).
Other “do not” recommendations include the use of alternate methods such as herbal remedies, castor oil,
homeopathy, sexual intercourse as examples of there being insufficient evidence to recommend their use.
When discussing induction of labour women must be informed of the:
 Process involved in induction, including:
o expected time of admission or outpatient attendance
o in either the inpatient or outpatient setting, whether support people are able to stay
o methods involved in induction including monitoring, vaginal exams and medical/mechanical
methods
o expected course of the induction, including time estimates
o variations in the course of induction which might include systems issues, individual variations
and delays
o options for management for variations of induction
o options for failure of induction
 Possible risks of induction (balanced with the risks of not inducing the labour, specific to the
individual woman and her indication for IOL), including:
o Increased risks of hyperstimulation, failed induction and resultant caesarean section, infection,
prolonged hospitalisation, fetal distress, increased risk of admission to neonatal care
o Discussion of alternate options to induction
o Short and longer term consequences of complications including impact of caesarean section for
options in subsequent births
 Risks of not inducing labour, where evidence strongly supports induction for improved outcomes,
including:
o the increased risk of caesarean section
o meconium aspiration
o stillbirth
 Other commonly reported experiences of induction should also be discussed, such as:
o maternal discomfort
o interrupted sleep
o repeated vaginal exams
o monitoring and its impact on mobility during labour
o perception of increased pain associated with induction
 Information should be given in a non-biased manner with presentation of the facts. As a general
principle, clinicians should refrain from giving personal choices as to management options. All
clinicians should be aware of their own personal bias and interpretation of the data. It is difficult as a
clinician not to bring our own perspective and experience into each conversation. Clinicians should
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
be aware of the spectrum of philosophies around birth and our ability to interpret data within that
spectrum.
Each woman and her family will have a different perspective of risk. For example, a 1:1,000 risk may be
acceptable to one woman but unacceptable to another in the apparent same circumstance. Women may
also accept a much higher risk to themselves than to their baby. Studies have shown that a woman will
generally accept a risk 100 times higher for themselves, than the risk for their baby.
The woman will be influenced by her relationship with her partner, her friends and family. As health
professionals we must be able to understand this influence and its impact on the woman’s conceptualising
the information that is presented.
Discussions around risks and benefits of a particular intervention will, on occasion, present a dilemma
between the woman’s right to choose versus our perception of “first do no harm”. This is particularly the
case when a clinician sees the choices made by a woman as contrary to the advice that is being offered.
These are challenging clinical situations for maternity care providers. The challenge may be so great in an
elective clinical situation, that referral to another clinician may be advisable.
In summary, conversation around induction of labour should be able to give the woman a realistic
expectation of why she is being recommended an induction, her options regarding the process involved and
the options should this not be her preferred pathway. The conversation should be able to pass the ‘hindsight
test’, that is, will there be components of the outcome that would have altered her understanding and
consent to proceed had she been made aware, of them? When outcomes are as expected and wished for
there is likely to be high levels of satisfaction.
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
Section 2: Induction of labour for women giving birth for the first time
There are many indications that are currently used to support the decision to recommend to women that
their labour should be induced. However there is no evidence to support all indications.
The Australian Institute of Health and Welfare (AIHW) National Perinatal Data Collection lists the following
indications being used for induction of labour (AIHW, 2014):
Prolonged pregnancy
Diabetes
Prelabour rupture of membranes
Hypertensive disorders
Multiple pregnancy
Cholestasis of pregnancy
Chorioamnionitis (includes suspected)
Antepartum haemorrhage
Maternal age
Maternal mental health indication
High Body Mass Index (BMI)
Previous adverse perinatal outcome
Other maternal obstetric or medical indication
Fetal growth restriction (includes suspected)
Fetal compromise (includes suspected)
Fetal macrosomia (includes suspected)
Fetal death
Fetal congenital anomaly
Administrative or geographical indication
Maternal choice in the absence of any obstetric,
medical, fetal, administrative or geographical
indication
While it is not possible to for this document to investigate every indication for induction of labour, it is
possible to identify in which indications induction of labour are supported by Level I or II evidence, and which
indications are not.
Indications for which there is strong evidence of benefit from induction of labour
In brief, WHA members agree that there is Level I or II evidence that women presenting with the following
indications should be offered induction of labour to improve outcomes:
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Women with prolonged pregnancy of 41 completed weeks or more (41.0)
Women with hypertensive disorders of pregnancy
Chorioamnionitis
Premature pre labour rupture of membranes at >37 completed weeks
Confirmed fetal growth restriction, and
Confirmed fetal macrosomia
Indications for which there is currently no strong evidence of benefit from induction of labour
WHA members agree that the following indications for induction are not supported by Level I or II evidence.
Therefore, women presenting with any of these indications should not be routinely offered induction of
labour, as there is weak or insufficient evidence to suggest that induction would improve outcomes for such
women and their babies:
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Maternal request in the absence of clinical indication
Women with an uncomplicated pregnancy at less than 41 completed weeks of gestation (40+7)
Well controlled GDM
Suspected IUGR/ SGA babies (without U/S confirmation)
Suspected fetal macrosomia (without U/S confirmation)
Maternal mental health indication
Breech presentation
High maternal BMI in the absence of other risk factors
Previous stillbirth without indications for IOL in the current pregnancy
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
Further, WHA members acknowledge a lack of evidence in relation to a number of indications, meaning
clinical judgement must be used, taking into consideration the evidence available, maternal preference and
resources available at the intended place of birth. Further research is needed before any of the following
indications can be considered cause for routinely offering induction:
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Poorly controlled GDM, with or without fetal macrosomia
Multiple pregnancy
Advanced maternal age
High BMI in conjunction with other risk factors
Cholestasis of pregnancy, and
Ante-partum haemorrhage.
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
Part A: Which women should be offered induction and when?
2.1 Induction of labour for women at or beyond term
A Cochrane intervention review on induction at or beyond term for women with normal pregnancies was
published in 2012. The review included 22 trials, which were generally at moderate risk of bias, reporting
on 9,383 women. In 17 trials (7,407 women), compared with a policy of expectant management, a policy
of labour induction was associated with fewer (all-cause) perinatal deaths: risk ratio (RR) 0.31, (95%
confidence interval (CI) 0.12 to 0.88). There was one perinatal death in the labour induction policy group
compared with 13 perinatal deaths in the expectant management group. The number needed to treat to
benefit (NNTB) with induction of labour in order to prevent one perinatal death was 410 (95% CI 322 to
1492).
The majority of trials adopted a policy of induction at 41 completed weeks (287 days) or more.
In eight trials (2,371 babies), fewer babies in the labour induction group had meconium aspiration
syndrome (RR 0.50, 95% CI 0.34 to 0.73) compared with a policy of expectant management. In 10 trials
(6,161 babies) there was no statistically significant difference between the rates of neonatal intensive care
unit (NICU) admission for induction compared with expectant management (RR 0.90, 95% CI 0.78 to 1.04).
For women in the policy of induction arms of trials (21 trials, 8,749 women), there were significantly fewer
caesarean sections compared with expectant management women (RR 0.89, 95% CI 0.81 to 0.97).
Consensus on recommended practice:
Compared with expectant management, a policy of labour induction from 41 weeks gestation compared
with expectant management is associated with fewer perinatal deaths, fewer caesarean sections and
lower rates of meconium aspiration syndrome. However, the absolute risk of perinatal death is small. There
is no statistically significant difference in the rate of neonatal intensive care admission.
Implications for practice:
Women should be appropriately counselled in order to make an informed choice, based on their personal
circumstances, between scheduled induction for a post-term pregnancy or monitoring without induction
(or delayed induction).
Reference:
Gülmezoglu AM, Crowther CA, Middleton P, Heatley E. Induction of labour for improving birth outcomes
for women at or beyond term. Cochrane Database of Systematic Reviews 2012, Issue 6.
Art.No.:CD004945. DOI: 10.1002/14651858.CD004945.pub3.
Available at: http://www.cochrane.org/CD004945/PREG_induction-of-labour-in-women-with-normalpregnancies-at-or-beyond-term Accessed 1/2/2016
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
2.2 Induction of labour for improving birth outcomes for women with gestational hypertension
or pre-eclampsia
The HYPITAT study assessed the difference between induction of labour and expectant monitoring in
756 women with hypertensive disorders of pregnancy between 36 and 41 weeks of gestation, and
showed that IOL after 37 weeks lead to a decrease of progression to severe disease or maternal
complications [31% versus 44%; RR: 0.71 (95% CI: 0.59-0.86 p<0.001)] without increasing the
caesarean section rate [RR 0.75 (95% CI: 0.55–1.04)] or risk of instrumental delivery [RR 0.93 (95% CI
0.65–1.33; p=0.694)]. A subgroup analysis found that the beneficial effect of induction of labour was
absent in women less than 37 weeks’ gestation. The number needed to treat to benefit (NNTB) with
induction of labour in order to prevent one adverse maternal outcome, mostly disease progression, was
8.
Subsequently, the HYPITAT II study investigated induction of labour in 703 women with hypertensive
disorders of pregnancy between 34 and 37 weeks gestation. There was a non-significant decrease in
risk for maternal complications with IOL [1.1% of the immediate delivery group and 3.1% of the
expectant monitoring group (RR 0.36, 95% CI 0.12-1.11; p=0.069)], however, this group also displayed
a vastly increased risk of the infant developing respiratory distress syndrome [5.7% on neonates in the
immediate delivery group versus 1.7% in the expectant monitoring group (RR 3.3, 95% CI 1.4-8.2)].
While for women with chronic hypertension in pregnancy randomised clinical trials are lacking, there are
population based studies that suggest a strongly increased risk of still birth in these women from 38
completed weeks of gestation onwards (Von Dadelszen P, Broekhuijsen K). In view of these data, and in
view of the lack of harm of induction in women in comparable condition, in women with chronic
hypertension induction of labour should be considered at 38 completed weeks.
Consensus on recommended practice:
For women with hypertensive disease, a policy of induction of labour can be suggested as:
 At 37 weeks gestation for women with stable pre-eclampsia
 At 39 weeks gestation for women with controlled gestational hypertension
 At 38 weeks gestation for women with chronic hypertension
Implications for practice:
Women should be appropriately counselled in order to make an informed choice between scheduled
induction for a pregnancy complicated by hypertensive disease or monitoring without induction (or
delayed induction).
References:
Koopmans CM, Bijlenga D, Groen H, Vijgen SMC, Aarnoudse JG, Bekedam DJ, et al. Induction of labour
versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks'
gestation (HYPITAT): a multicentre, open-label randomised controlled trial. The Lancet;
374
(9694):979-88.
Broekhuijsen, Kim et al. Delivery versus expectant monitoring for late preterm hypertensive disorders of
pregnancy (HYPITAT-II): a multicentre, open label, randomized controlled trial. American Journal of
Obstetrics & Gynecology , Volume 210 , Issue 1 , S2 - S3
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
2.3 Preterm premature rupture of the membranes
A Cochrane intervention review published in 2010 included seven trials (690 women) and identified no
difference in the primary outcomes of neonatal sepsis (risk ratio (RR) 1.33, 95% confidence interval (CI)
0.72 to 2.47) or respiratory distress (RR 0.98, 95% CI 0.74 to 1.29). Early delivery increased the incidence
of caesarean section (RR 1.51, 95%CI 1.08 to 2.10). There was no difference in the overall perinatal
mortality, intrauterine deaths, or neonatal deaths when comparing early delivery with expectant
management. There was no significant difference in measures of neonatal morbidity, including cerebroventricular haemorrhage, necrotising enterocolitis or duration of neonatal hospitalisation. With respect
to maternal outcomes, early delivery increased endometritis but had no effect on chorioamnionitis. There
was a significant reduction of early delivery on the duration of maternal hospital stay.
In 2015, the PPROMT multicentre randomised controlled trial was published (1839 women). Neonatal
sepsis occurred in 23 (2%) of the immediate birth group and 29 (3%) assigned to expectant management
(relative risk [RR] 0·8, 95% CI 0·5–1·3; p=0·37). The composite secondary outcome of neonatal morbidity
and mortality occurred in 73 (8%) in the immediate delivery group and 61 (7%) assigned to the expectant
management group (RR 1·2, 95% CI 0·9–1·6; p=0·32). However, neonates born to mothers in the
immediate delivery group had increased rates of respiratory distress (76 [8%] of 919 vs. 47 [5%] of 910,
RR 1·6, 95% CI 1·1–2·30; p=0·008) and any mechanical ventilation (114 [12%] of 923 vs. 83 [9%] of 912,
RR 1·4, 95% CI 1·0–1·8; p=0·02) and spent more time in intensive care (median 4·0 days [IQR 0·0–10·0]
vs. 2·0 days [0·0–7·0]; p<0·0001) compared with neonates born to mothers in the expectant management
group. Compared with women assigned to the immediate delivery group, those assigned to the
expectant management group had higher risks of antepartum or intrapartum haemorrhage (RR 0·6, 95%
CI 0·4–0·9), intrapartum fever (0·4, 0·2–0·9), and use of postpartum antibiotics (0·8, 0·7–1·0), and longer
hospital stay (p<0·0001), but a lower risk of caesarean delivery (RR 1·4, 95% CI 1·2–1·7).
Consensus on recommended practice:
IOL is not recommended for women who rupture their membranes at less than 37 weeks and show no
sign of infection or fetal compromise. Women should be appropriately counselled in order to make an
informed choice between scheduled induction for a pregnancy complicated by premature preterm
rupture of membranes from 37 weeks. Induction is recommended if there are signs of infection, fever or
tachycardia.
Implications for practice:
For management of pregnant women who present with ruptured membranes close to term, the risks of
intrauterine sepsis associated with continuation of the pregnancy need to be balanced against the risks
of prematurity if birth is planned immediately. In the absence of signs of intrauterine sepsis it would be
appropriate to counsel women that expectant management until 37 weeks is appropriate.
References:
Buchanan SL, Crowther CA, Levett KM, Middleton P ,Morris J. Planned early birth versus expectant
management for women with preterm prelabour rupture of membranes prior to 37 weeks’ gestation for
improving pregnancy outcome. Cochrane Database of Systematic Reviews 2010, Issue 3. Art. No.:
CD004735. DOI: 10.1002/14651858.CD004735.pub3.
Morris JM, Roberts CL, Bowen JR, Patterson JA, Bond DM, Algert CS, et al. Immediate delivery
compared with expectant management after preterm pre-labour rupture of the membranes close to term
(PPROMT trial): a randomised controlled trial. The Lancet. 2015. dx.doi.org/10.1016/S01406736(15)00724-2
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
2.4 Term premature (prelabour) rupture of membranes
A Cochrane intervention review published in 2006 of twelve trials (6814 women) compared planned early
birth (induction with oxytocin or prostaglandin), with expectant management (waiting). Overall, no
differences were detected for mode of birth between planned and expectant groups: relative risk (RR) of
caesarean section 0.94, 95% confidence interval (CI) 0.82 to 1.08; RR of operative vaginal birth 0.98,
95% 0.84 to 1.16. Significantly fewer women in the planned compared with expectant management
groups had chorioamnionitis (RR 0.74, 95% CI 0.56 to 0.97) or endometritis (RR 0.30, 95% CI 0.12 to
0.74). No difference was seen for neonatal infection (RR 0.83, 95% CI 0.61 to 1.12). However, fewer
infants under planned management went to neonatal intensive or special care compared with expectant
management (RR 0.72, 95% CI 0.57 to 0.92, number needed to treat 20). In a single trial, significantly
more women with planned management viewed their care more positively than those expectantly
managed (RR of “nothing liked” 0.45, 95% CI 0.37 to 0.54).
Consensus on recommended practice:
Induction of labour in women with term (> 37 weeks) premature (prelabour) rupture of membranes
reduces the risk of some maternal infectious morbidity without increasing caesarean sections and
operative vaginal births. Fewer infants are admitted to neonatal intensive care under planned
management although no differences are seen in neonatal infection rates.
Implications for practice:
For management of pregnant women who present with ruptured membranes at term the risks of infection
associated with continuation of the pregnancy need to be discussed. Other considerations such as GBS
status or the length of time the membranes have been ruptured will influence the management plan.
Women should be appropriately counselled in order to make an informed choice between scheduled
induction for a pregnancy complicated by term premature (prelabour) rupture of membranes or
monitoring without induction (or delayed induction).
References:
Dare MR, Middleton P, Crowther CA, Flenady V, Varatharaju B. Planned early birth versus expectant
management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane
Database of Systematic Reviews 2006, Issue 1. Art. No.: CD005302.
DOI:10.1002/14651858.CD005302.pub2.
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
2.5 Suspected intrauterine growth restriction at term
A Cochrane intervention review published in 2015 included three trials (546 participants: 269 to early
delivery and 277 to expectant management). All three trials were of reasonable quality and at low risk of
bias. The level of evidence was graded moderate, low or very low, downgrading mostly for imprecision
and for some indirectness. Overall, there was no difference in the primary neonatal outcomes of perinatal
mortality, major neonatal morbidity (risk ratio (RR) 0.15, 95% confidence interval (CI) 0.01 to 2.81), or
neurodevelopmental disability/impairment at two years of age (RR 2.04, 95% CI 0.62 to 6.69). There was
no difference in the risk of necrotising enterocolitis or meconium aspiration. There was also no difference
in the reported primary maternal outcomes: maternal mortality and significant maternal morbidity. The
gestational age at birth was on average 10 days earlier in women randomised to early delivery (mean
difference (MD) -9.50, 95% CI -10.82 to -8.18, one trial, 459 women) and women in the early delivery
group were significantly less likely to have a baby beyond 40 weeks’ gestation (RR 0.10, 95% CI 0.01 to
0.67, one trial, 33 women). Significantly more infants in the planned early delivery group were admitted
to intermediate care nursery (RR 1.28, 95% CI 1.02 to 1.61). There was no difference in the risk of
respiratory distress syndrome, Apgar score <7 at 5 minutes, resuscitation required, mechanical
ventilation, admission to NICU, length of stay in NICU/SCN, and sepsis. Babies in the expectant
management group were more likely to be <2.3rd centile for birthweight (RR 0.51, 95% CI 0.36), however
there was no difference in the proportion of babies with birthweight < 10th centile (RR 0.98, 95% CI 0.88
to 1.10). There was no difference in any of the reported maternal secondary outcomes including:
caesarean section rates, placental abruption, pre-eclampsia, vaginal birth, assisted vaginal birth,
breastfeeding rates and number of weeks of breastfeeding after delivery. There was an expected
increase in induction in the early delivery group (RR 2.05, 95% CI 1.78 to 2.37).
Consensus on recommended practice:
Induction of labour in women at term (> 37 weeks) with suspected intrauterine growth restriction with no
evidence of fetal compromise has neither demonstrated benefit for the fetus nor any demonstrated
maternal harm. For management of pregnancy at term with suspected intrauterine fetal growth restriction
the risks associated with continuation of the pregnancy need to be discussed. Other considerations will
influence the management plan. Women should be appropriately counselled in order to make an
informed choice between scheduled induction or monitoring without induction (or delayed induction).
Implications for practice:
For healthy pregnant women at term, several factors can indicate that the baby’s health is at risk. These
may be based on either clinical examination or history. Babies not growing appropriately (intrauterine
growth restriction) or showing a decrease in their movements may indicate placental pathology. While
investigations such as cardiotocography (CTG) and ultrasound can assess the baby’s well-being, these
modalities have recognised limitations including recognised variability in ultrasound assessment of fetal
weight and limited ability for a CTG to assess fetal wellbeing beyond the time period that the CTG is
actually in place. Moreover, the ability of Doppler to determine fetal compromise at term remains limited
with ongoing research underway. Results that are clearly abnormal and associated with increased risk
for the baby require immediate delivery, but the management for ‘suspicious’ results remains unclear.
The balance between allowing the pregnancy to continue for full lung development has to be weighed
against removing the baby from an environment that is suspected to be harmful. The best timing of
delivery for women presenting with a suspected compromised baby in an otherwise healthy term
pregnancy is unclear. Women should be appropriately counselled in order to make an informed choice
between scheduled induction for a pregnancy complicated by suspected intrauterine growth restriction
or ongoing monitoring without induction (or delayed induction).
References:
Bond DM, Gordon A, Hyett J, de Vries B, Carberry AE, Morris J. Planned early delivery versus expectant
management of the term suspected compromised baby for improving outcomes. Cochrane Database of
Systematic Reviews 2015, Issue 11. Art. No.: CD009433. DOI: 10.1002/14651858.CD009433.pub2.
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
2.6 Suspected fetal macrosomia at term
A Cochrane intervention review published in 2016 included four trials, involving 1,190 women. Compared
to expectant management, there was no clear effect of induction of labour for suspected macrosomia
on the risk of caesarean section (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.76 to 1.09) or
instrumental delivery (RR 0.86, 95% CI 0.65 to 1.13). Shoulder dystocia (RR 0.60, 95% CI 0.37 to 0.98),
and fracture (any) (RR 0.20, 95% CI 0.05 to 0.79) were reduced in the induction of labour group. There
were no clear differences between groups for brachial plexus injury. There was no strong evidence of
any difference between groups for measures of neonatal asphyxia; low five-minute infant Apgar scores
(less than seven) or low arterial cord blood pH (RR 1.51, 95% CI 0.25 to 9.02; and RR 1.01, 95% CI 0.46
to 2.22 respectively). Mean birthweight was lower in the induction group, but there was considerable
heterogeneity between studies for this outcome (mean difference (MD) -178.03 g, 95% CI -315.26 to 40.81). In one study with data for 818 women, third and fourth-degree perineal tears were increased in
the induction group (RR 3.70, 95% CI 1.04 to 13.17).
A 2002 systematic review of two RCT and nine observational trials compared maternal and neonatal
outcomes among women with suspected fetal macrosomia (3,600–4,500 g) who were induced (N=1,051)
or managed expectantly (N=2,700). There was no significant difference in shoulder dystocia, 5-minute
Apgar scores <7, or instrumental vaginal delivery. The observational trials (n=3,438) had a significantly
lower incidence of caesarean sections with expectant management than with induction (8.4% vs. 17%;
OR 0.39; 95% CI, 0.30–0.50), although this difference was not found in the RCTs (n=313) (24% vs. 21%;
OR 1.2; 95% CI, 0.69–2.0).
A multicentre randomised controlled trial comparing induction of labour with expectant management for
large-for-date fetuses for prevention of shoulder dystocia and other neonatal and maternal morbidity
associated with macrosomia was published in 2015. Women with singleton fetuses with estimated
weight > 95th percentile, were randomly assigned to receive induction of labour within 3 days between
37+0 weeks and 38+6 weeks of gestation, or expectant management. Induction of labour significantly
reduced the risk of shoulder dystocia or associated morbidity (n=8) compared with expectant
management (n=25; relative risk [RR] 0·32, 95% CI 0·15–0·71; p=0·004), however, there were no brachial
plexus injuries, intracranial haemorrhages, or perinatal deaths. The likelihood of spontaneous vaginal
delivery was higher in women in the induction group than in those in the expectant management group
(RR 1·14, 95% CI 1·01–1·29). Caesarean delivery and other neonatal morbidity did not differ significantly
between the groups.
Consensus on recommended practice:
Induction of labour in women at term (>37 weeks) with suspected fetal macrosomia has neither
demonstrated benefit for the fetus nor any demonstrated maternal harm. For management of pregnancy
at term with suspected fetal macrosomia the risks associated with continuation of the pregnancy need
to be discussed. Other considerations will generally influence the management.
Implications for practice:
Suspected fetal macrosomia may be based either on clinical examination but more usually on ultrasound
measurements. In terms of fetal biometry and estimates of fetal weight, the reliability of ultrasound at
term to detect larger babies is poor. Ultrasound variability in fetal biometry performed by trained
sonographers under standardised conditions is found to increase with gestational age when expressed
in millimetres, but is constant as a percentage of the fetal dimensions. Measurement variability can be
large and should be considered when interpreting fetal growth rates. Thus the management for
‘suspicious’ results remains unclear. The best timing of delivery for women presenting with a suspected
macrosomic baby in an otherwise healthy term pregnancy is unclear. Women should be appropriately
counselled in order to make an informed choice between scheduled induction for a pregnancy
complicated by suspected macrosomia or expectant management.
References:
Boulvain M, Irion O, Dowswell T, Thornton JG. Induction of labour at or near term for suspected fetal macrosomia.
Cochrane Database of Systematic Reviews 2016, Issue 5. Art. No.: CD000938. DOI:
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
10.1002/14651858.CD000938.pub2.Sanchez-Ramos L, Bernstein S, Kaunitz AM. Expectant Management Versus
Labor Induction for Suspected Fetal Macrosomia: A Systematic Review. Obstetrics & Gynecology. 2002;100(5,
Part 1):997-1002.
Boulvain M, Senat M-V, Perrotin F, Winer N, et al. Induction of labour versus expectant management for large-fordate fetuses: a randomised controlled trial. The Lancet. 27;385(9987):2600-5.
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
Part B: What methods of induction are utilised?
A Cochrane intervention review published in 2012 included 71 randomised control trials with a total of
9,722 women. The review compared mechanical methods used for third trimester cervical ripening or
labour induction with placebo/no treatment, prostaglandins and oxytocin. Mechanical methods of
induction included laminaria tents, catheter insertion into extra-amniotic space with or without traction,
and catheter use to inject fluid into extra-amniotic space.
When mechanical methods were compared with no treatment, the risk of caesarean section was found
to be similar between groups (RR 1.00; 95% CI 0.76 to 1.30). There were no cases of severe neonatal
and maternal morbidity.
Mechanical methods compared with vaginal PGE2 did not show significantly different rates for achieving
vaginal delivery within 24 hours (RR 1.72; 95% CI 0.90 to 3.27). However, multiparous women were at
higher risk of not achieving delivery within 24 hours (RR 4.38, 95% CI 1.74 to 10.98), with no increase in
caesarean sections (RR 1.19, 95% CI 0.62-2.29).
The review found that mechanical methods reduced the risk of uterine hyperstimulation in combination
with fetal heart rate changes when compared with vaginal prostaglandins (RR 0.16; 95% CI 0.06to 0.39).
The risk of caesarean section between mechanical methods and prostaglandins was found to be
comparable, and serious neonatal and maternal morbidity were seldom reported, with no difference seen
between the groups.
Mechanical methods of induction compared with oxytocin alone reduced the risk of caesarean section
(RR 0.62; 95% CI 0.42 to 0.90). The likelihood of vaginal delivery within 24 hours was not reported, and
uterine hyperstimulation with fetal heart rate changes was reported in one study (200 participants) with
no difference noted. There were no reported cases of severe maternal or neonatal morbidity. A
subsequent systematic review and meta-analysis published in 2015 concluded that the use of
transcervical Foley balloon catheters for cervical ripening and induction of labour is not associated with
an increased risk of infectious morbidity.
Consensus on recommended practice:
Mechanical methods of cervical ripening/induction of labour result in a lower incidence of uterine
hyperstimulation. Given the comparable outcomes in terms of caesarean section rates and low incidence
of any severe maternal or neonatal morbidity, mechanical methods of cervical ripening/induction of
labour should be considered appropriate for women with an unfavourable cervix without
contraindications.
Implications for practice:
Mechanical methods are as effective as prostaglandins in achieving delivery within 24 hours with fewer
episodes of excessive uterine contractions. The risk of caesarean section is no different. Mechanical
methods can be considered to have fewer side effects compared with prostaglandins. With respect to
maternal discomfort, more discomfort during ripening has been reported with prostaglandins compared
with Foley catheter, and with double balloon devices compared with Foley catheters.
References:
Jozwiak, M., Bloemenkamp, K. W., Kelly, A. J., Mol, B. W., Irion, O., & Boulvain, M. (2012). Mechanical methods
for induction of labour. Cochrane Database of Systematic Reviews(3). doi:10.1002/14651858.CD001233.pub2
McMaster KM, Sanchez-Ramos L, Kaunitz AM. Does Cervical Ripening With Foley Catheters Increase Infectious
Morbidity? A Systematic Review With Meta-analysis [36]. Obstetrics & Gynecology. 2015;125:64S. PubMed PMID:
00006250-201505001-00214.
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
Part C: Where should cervical ripening take place?
There is no high level evidence at this time.
Consensus on recommended practice:
Services should develop their own protocols for the place of cervical ripening.
Implications for practice:
Services should be prepared to participate in research to answer this important clinical question.
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WHA Consensus Statement on induction of labour for first time mothers, November 2016
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