Cromi 2011.

Methods	RCT
Participants	Inclusion: singleton gestation, vertex presentation, BS ≤ 6, intact membranes, GA ≥ 34 weeks, reassuring FHR tracing Exclusion: Women with antepartum bleeding, intrauterine fetal death, previous uterine scars, known allergy to latex, placenta previa, contraindication to vaginal delivery
Interventions	24‐hour Foley (n = 133): 18F, 50cc, 24 hours 12‐hour Foley (n = 132): 18F, 50cc, 12 hours PGE2 vaginal insert 10 mg (n = 132): vaginal fornix, 24 hours
Outcomes	vaginal delivery within 24 hours, improvement in BS after ripening, caesarean delivery, ripening‐to‐delivery interval, oxytocin administration, epidural request, neonatal outcomes.
Notes	Setting:Obstetrics Department of University of Insubria, Varese, Italy. Study period: July 2008 to June 2010 Funding: none reported Declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated block randomisation
Allocation concealment (selection bias)	Unclear risk	Allocation not reported
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