Niromanesh 2003.

Study characteristics
Methods	Quote:"randomly assigned".
Participants	BS < 5, maternal age 20 to 30 years, gravidity 1 ‐ 3, parity 1 ‐ 2, < 6 contractions per hour, singleton pregnancy. Exclusion: history of preterm labour, antepartum bleeding, low‐lying placenta, history of caesarean deliveries, active herpes infection, acute poly or oligohydramnios, high blood pressure, IUFD, GA < 40 weeks, chronic condition or contraindication for use of PGs.
Interventions	Foley catheter 30 mL max 8 hours (n = 45). (PGE2) tablet 6‐hourly, max 6 doses (n = 44).
Outcomes	Primary: BS (after ripening). Secondary: ripening time, induction time, total time, delivery route, uterine hyperstimulation, adverse side effects, non‐reassuring FHR tracing, AS.
Notes	No sample size calculation. 1 patient withdrew due to 'complications'. Time of ripening in Foley group 8 hours, PG group 12 hours Setting: Mirza Kochkhan Hospital, Tehran, Iran. Study period: March 2000 to May 2001 Funding sources: not reported Declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number table.
Allocation concealment (selection bias)	Low risk	Sealed opaque envelope.
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	Unclear risk	No mention of incomplete data, insufficient information to permit judgment.
Selective reporting (reporting bias)	Unclear risk	1 patient was withdrawn due to 'complications', data for this patient not reported, other than this, data reported for all patients on the prespecified outcomes.
Other bias	Low risk	No other bias detected