Mackeen 2018.

Study characteristics
Methods	RCT
Participants	Inclusion criteria: women with a live, singleton gestation in cephalic presentation at 34 weeks of gestation or greater with PROM (at least 60 minutes prior to randomisation), an unfavourable cervical examination (less than 2 cm or 80% effaced), and no contraindication to labour. English speaking with a plan for vaginal delivery. Exclusion criteria: active labour and those with suspected intra‐amniotic infection, abruption or significant haemorrhage, latex allergy, greater than 1 prior caesarean delivery, any contraindication to vaginal delivery, or human immunodeficiency virus or acquired immunodeficiency syndrome, multifetal gestations, lethal fetal anomalies, intrauterine fetal demise, and category II or III FHR tracings.
Interventions	Oxytocin only (n = 108): start 2 mUh/minute, increase 2 mUh/minute every 30 minute, max 30 mUh/minute Foley catheter + oxytocin (n = 93): 16F, 30 mL, traction applied, max 12 hours, oxytocin concurrent (as above) If not in labour after 24 hours, management per discretion of clinician
Outcomes	Interval from induction to delivery, interval from induction to vaginal delivery, induction to delivery excluding patients with PPROM before 34 weeks of GA, CS rate, rate of vaginal delivery within 12 or 24 hours, indication for CS, infection complications, maternal LOS, 5‐minute AS < 5, neonatal infectious evaluation and diagnosis of sepsis, maternal and neonatal length of stay, NICU admission, chorioamnionitis, fetal tachycardia, endomyometritis,
Notes	Setting: multicentre, USA Study period: March 2014 to July 2016 Funding: small internal grants to assist with the conduct and statistical analyses for the entire study. Declarations of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated schema in random‐sized blocks stratified by multiparity or primiparity, preterm or term gestation, and hospital site.
Allocation concealment (selection bias)	High risk	Not concealed.
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 data or cases
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes were reported in results
Other bias	Low risk	No other bias detected