ten Eikelder 2016.

Study characteristics
Methods	RCT
Participants	Inclusion: singleton, scheduled for labour induction, GA ≥ 37 wk; BS < 6, vertex presentation, intact membranes. Exclusion: placenta previa, previous uterine scar. contraindication to receive or known allergy to latex or PG.
Interventions	1. Foley catheter (n = 921): 30 mL, no traction, replaced after 48 hours, max 4 days 2. Low dose oral misoprostol (n = 924): 50 mg every 4 hours, max 3 times a day, max 4 days
Outcomes	Primary outcome for safety was composite of fluxus postpartum and asphyxia, and for effectiveness CS rate. Secondary outcomes included maternal and neonatal outcomes, total induction time, interval between randomisation and active phase
Notes	Setting: multicentre, 6 tertiary‐care and 23 secondary‐care hospitals, the Netherlands Study period: July 2012 to October 2013, Funding: FondsNutsOhra, no role in study design, data collection, data analysis, data interpretation, writing of the report or publication Declarations of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated numbers, block randomisation, stratified by parity and centre
Allocation concealment (selection bias)	Low risk	Web‐based allocation
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not feasible due to nature of intervention
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT, no missing cases. missing data in primary outcome (pH in umbilical artery). similar reasons for missing data across groups, pre‐specified in protocol, anticipated on as followed: data missing for umbilical artery pH and a 5‐minute AS of less than 7, the outcome was classified as abnormal; for patients with missing data for umbilical artery pH and a 5‐minute AS of 7 or more, the neonatal outcome was classified as normal.
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes were reported in results
Other bias	Low risk	No other bias detected