title: Effects of induction of labour versus expectant management in women with impending post-term pregnancies: the 41 week - 42 week dilemma.
abstract: BACKGROUND
  Post-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
  In 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.
  
  
  CONCLUSIONS
  This study will provide evidence for the management of pregnant women reaching a gestational age of 41 weeks.
  
  
  BACKGROUND
  Dutch Trial Register (Nederlands Trial Register): NTR3431. Registered: 14 May 2012.
authors.affiliation: Department of Obstetrics & Gynaecology, Radboud University Medical Center, Nijmegen, the Netherlands. joep.kortekaas@radboudumc.nl.
authors.forename: Joep C
authors.initials: JC
authors.lastname: Kortekaas
authors.forename: Aafke
authors.initials: A
authors.lastname: Bruinsma
authors.forename: Judit K J
authors.initials: JK
authors.lastname: Keulen
authors.forename: Jeroen
authors.initials: J
authors.lastname: van Dillen
authors.forename: Martijn A
authors.initials: MA
authors.lastname: Oudijk
authors.forename: Joost J
authors.initials: JJ
authors.lastname: Zwart
authors.forename: Jannet J H
authors.initials: JJ
authors.lastname: Bakker
authors.forename: Dokie
authors.initials: D
authors.lastname: de Bont
authors.forename: Marianne
authors.initials: M
authors.lastname: Nieuwenhuijze
authors.forename: Pien M
authors.initials: PM
authors.lastname: Offerhaus
authors.forename: Anton H
authors.initials: AH
authors.lastname: van Kaam
authors.forename: Frank
authors.initials: F
authors.lastname: Vandenbussche
authors.forename: Ben Willem J
authors.initials: BW
authors.lastname: Mol
authors.forename: Esteriek
authors.initials: E
authors.lastname: de Miranda
mesh_terms: D000328:Adult; D002585:Cesarean Section; D036861:Delivery, Obstetric / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D005260:Female; D005323:Fetal Monitoring / Q000379:methods; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D007223:Infant; D007226:Infant Mortality / Q000639:trends*; D007231:Infant, Newborn; D053208:Kaplan-Meier Estimate; D007751:Labor, Induced / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D009426:Netherlands; D011247:Pregnancy; D011256:Pregnancy Outcome; D011273:Pregnancy, Prolonged; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014219:Trial of Labor; D055815:Young Adult