Effects of induction of labour versus expectant management in women with impending post-term pregnancies: the 41 week – 42 week dilemma

Abstract

BackgroundPost-term pregnancy, a pregnancy exceeding 294 days or 42 completed weeks, is associated with increased perinatal morbidity and mortality and is considered a high-risk condition which requires specialist surveillance and induction of labour. However, there is uncertainty on the policy concerning the timing of induction for post-term pregnancy or impending post-term pregnancy, leading to practice variation between caregivers. Previous studies on induction at or beyond 41 weeks versus expectant management showed different results on perinatal outcome though conclusions in meta-analyses show a preference for induction at 41 weeks. However, interpretation of the results is hampered by the limited sample size of most trials and the heterogeneity in design. Most control groups had a policy of awaiting spontaneous onset of labour that went far beyond 42 weeks, which does not reflect usual care in The Netherlands where induction of labour at 42 weeks is the regular policy. Thus leaving the question unanswered if induction at 41 weeks results in better perinatal outcomes than expectant management until 42 weeks.Methods/designIn this study we compare a policy of labour induction at 41 + 0/+1 weeks with a policy of expectant management until 42 weeks in obstetrical low risk women without contra-indications for expectant management until 42 weeks and a singleton pregnancy in cephalic position. We will perform a multicenter randomised controlled clinical trial. Our primary outcome will be a composite outcome of perinatal mortality and neonatal morbidity. Secondary outcomes will be maternal outcomes as mode of delivery (operative vaginal delivery and Caesarean section), need for analgesia and postpartum haemorrhage (≥1000 ml). Maternal preferences, satisfaction, wellbeing, pain and anxiety will be assessed alongside the trial.DiscussionThis study will provide evidence for the management of pregnant women reaching a gestational age of 41 weeks.Trial registrationDutch Trial Register (Nederlands Trial Register): NTR3431. Registered: 14 May 2012.

Induction of labour at 41 weeks versus expectant management until 42 weeks (INDEX): multicentre, randomised non-inferiority trial

“…Our protocol has been published previously. 31 The study was performed within the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynaecology in cooperation with the Midwifery Research Network Netherlands.…”

Perinatal death beyond 41 weeks pregnancy: an evaluation of causes and substandard care factors as identified in perinatal audit in the Netherlands

“…Controversy about the clinical management of an uncomplicated pregnancy reaching 41 weeks concerns the question whether labour should be induced at 41.0 weeks or if expectant management until 42.0 weeks could be allowed considering the prevention of adverse perinatal outcomes such as perinatal death [ 1 , 4 , 6 , 10 , 11 ]. In the Netherlands, this question has been identified by Dutch midwives and gynaecologists as the main dilemma in obstetrical policy in the term period resulting in the INDEX trial: a randomised clinical trial in which effects and costs of both induction of labour at 41.0 weeks and expectant management until 42.0 weeks are studied [ 12 ].…”

Midpregnancy Cervical Length in Nulliparous Women and its Association with Postterm Delivery and Intrapartum Cesarean Delivery

“…In the Netherlands there is an ongoing study comparing induction of labor versus expectant management in women with impending postterm pregnancies. 39 The prediction of successful induction of labor in late-term or postterm pregnancies and the role of ultrasound cervical assessment for this purpose, has been subject of several studies. 14,40,41 At least two studies found an increased risk of (impending) postterm pregnancy and emergency cesarean section if cervical length measured > 37 weeks of gestation is long.…”

“…43 mm [interquartile range, IQR 39-49 vs. 43 mm [IQR[38][39][40][41][42][43][44][45][46][47][48][49]] p ¼ 0.06). Among those 12,360 women, 6,233 were multiparous women and 806 were excluded because they otherwise did not meet the inclusion criteria (►Fig.…”