Walker 2016.

Study characteristics
Methods	RCT
Participants	Number of women randomised: 619 Setting: 39 National Health Service hospitals, UK Study date: women recruited August 2012 to March 2015 Inclusion criteria GA: between 360 and 396 weeks Nulliparous 35 years or older on due date Singleton, live fetus in cephalic presentation Exclusion criteria Pregnancy complicated by known fetal abnormality that would lead to neonatal death Any contraindications to labour, vaginal birth, or EM Undergone myomectomy Uncertain dates (no ultrasound < 22 weeks) Undergone IVF with donor eggs State of cervix: not clearly reported (mixed)
Interventions	Induction group (n = 305): IOL between 390 and 396 weeks, with method dependent on local protocol and cervical ripeness (most participating units used prostaglandin ripening followed, if necessary, by AROM and oxytocin). Prostaglandin tablet regimen (n = 49), prostaglandin gel regimen (n = 63), prostaglandin slow release pessary (N = 158), AROM (n = 129), oxytocin (n = 137) (women could have > 1 intervention) versus EM group (n = 314): waiting for spontaneous onset of labour, unless a situation developed necessitating birth by IOL or caesarean. Women underwent IOL between 41‐42 weeks (7‐14 days after due date) depending on preference and physician's usual practice; if a woman declined induction at 42 weeks, she could undergo a scan to determine fetal growth and amniotic fluid volume daily or every other day, CTG and monitoring according to usual practice.
Outcomes	Mother: caesarean; method of birth; onset of labour; indication for induction; method of induction; indication for caesarean; intrapartum and postpartum complications (e.g. systemic infection, need for blood transfusion); mother’s expectations and experience of childbirth; analgesia; perineal trauma; postpartum haemorrhage Baby: live or stillbirth; birthweight; admission to NICU; birth trauma; 2 composite outcomes for serious neonatal complications (direct trauma and hypoxia); Apgar < 7 at 5 minutes
Notes	Staff were encouraged to use the same methods of IOL in the induction group and the EM group who were subsequently induced. Funding: Grant (PB‐PG‐0610‐22275) from the Research for Patient Benefit Programme of the National Institute for Health Research Declarations of interest: Dr. Smith reported receiving fees for serving on an advisory board from Roche Diagnostics, consulting fees from GlaxoSmithKline, equipment loans from Roche Diagnostics and General Electric, travel support from Roche Diagnostics and Chiesi, and grant support from GlaxoSmithKline and Action Medical Research, and being named as an inventor on a pending patent (PCT/EP2014/062602) filed by GlaxoSmithKline related to retosiban as a preventive treatment for preterm labour in women with increased uterine stretch. No other potential conflict of interest relevant to this article was reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	1:1 ratio using a computer‐generated code with the use of permuted blocks of randomly varying size generated by a clinical trials unit. Stratified by trial centre and maternal age
Allocation concealment (selection bias)	Low risk	Allocation was concealed by using central allocation by the Clinical Trials Unit
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding was not feasible.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinded outcome assessment was not mentioned.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Analysis included all but 1/619 women; 83% completed childbirth experience questionnaires
Selective reporting (reporting bias)	Low risk	Trial protocol published
Other bias	Low risk	Appeared to be free of other bias