Kruit 2016.

Methods	RCT
Participants	Inclusion: PROM > 18 hours, ≥ 37 weeks, BS < 6, vital singleton pregnancy, cephalic Exclusion: previous CS, placenta previa, vaginal bleeding, HIV, hepatitis B or C, maternal infection, fetal anomaly
Interventions	Foley (n = 89): 22ch Rush balloon, traction, 40‐50 cc, max 8 hours. if unripe, further management by discretion of clinician oral misoprostol (n = 99): 50 mcg misoprostol every 4 hours, after 3 gifts dosis increased to 100 mcg or 25 to 50 mcg vaginal every 3‐4 hours
Outcomes	CS rate, maternal and neonatal infections. Reason for CS (fetal distress, suspected infection, prolonged labour, failed induction, postpartum infection, postpartum haemorrhage, uterine hyperstimulation, fetal tachycardia, use of analgesics, AS, umbilical arterial pH, admission to neonatal care, induction to delivery interval.
Notes	Trial stopped prematurely due to insufficient patient enrolment Setting: multicentre, Finland Study period: March 2012 to September 2014 Funding: grant from the Finnish medical society duodecim and Helsinky University Central Hospital research grant Declarations of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported how this was done (only that they used sealed envelopes)
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
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	High risk	Seems to be per protocol analysis. Patients excluded after enrolment for cross‐over during analysing data, 3rd arm formed
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes reported
Other bias	High risk	Trial stopped prematurely due to insufficient patient enrolment