Amorosa 2017.

Methods	RCT
Participants	Inclusion: PROM, age ≥ 18 years, viable fetus, cephalic, singleton, GA > 34 weeks, < 3 cm dilation Exclusion: multifetal gestation, a known anomalous fetus, malpresentation, latex allergy, unexplained vaginal bleeding or contraindication to vaginal delivery (such as a placenta previa), antibiotics, previous uterine surgery, spontaneous labour
Interventions	Foley catheter (n = 61) 16F, 30 mL balloon filled with 60 mL saline, traction applied (no max time described), oxytocin started after 1 hour Oxytocin alone directly (n = 68) Oxytocin in both groups, started 2 mU/minute, max 30 mU/minute
Outcomes	The primary outcome measure was time from start of induction to delivery. Secondary outcomes included mode of delivery, tachysystole, chorioamnionitis, postpartum haemorrhage, neonatal AS, and admission to the NICU.
Notes	Setting: Mount Sinai Hospital, New York, USA Study period: August 2014 to September 2016 Funding: not reported Declaration of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated numbers
Allocation concealment (selection bias)	Low risk	Sequential numbered 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	Low risk	Modified ITT, (1 woman excluded who afterwards did not met the inclusion criteria), no missing data or cases
Selective reporting (reporting bias)	Low risk	All pre‐specified outcome measures were reported in results
Other bias	Low risk	No other bias detected