Henry 2013.

Study characteristics
Methods	RCT
Participants	Inclusion: women ≥ 18 years gestational > 37 weeks requiring IOL with a cervical preparation procedure Exclusion: unsuitable for outpatient management, unsuitable for randomisation to either PGE2 (e.g. previous CS) or catheter use (e.g. latex allergy), or prior attempted IOL in this pregnancy, ruptured membranes, regular uterine contractions, multiple pregnancy or non‐vertex presentation, unable to give informed consent
Interventions	Foley catheter (n = 50): 30 mL, slight traction, spigot inserted to occlude the lumen, PCM 1 g/60 mg codeine, 20 mg temazepam., went home. Next morning AROM or priming by choice of clinician (n = 50) PG gel (n = 51): (2 mg nulliparous – 1 mg multi parous), fornix posterior, repeated if necessary after 6 hours (1 mg), PCM 1 g/60 codeine, temazepam 20 mg, next morning AROM or priming by choice of clinician
Outcomes	Delivering vaginally within 12 hours of admission to Delivery Unit; total inpatient hours from induction to delivery, syntocinon for induction or augmentation of labour, mode of delivery, vaginal delivery within 24 hours of insertion of Foley catheter or first dose PGE2 gel, Induction to delivery interval, i.e. time from commencement of cervical ripening to delivery, delivery within 24 hours of insertion of Foley catheter or first dose PGE2 gel, requirement for second method of cervical ripening or (in Prostin group) 3rd dose of PG, patient satisfaction using questionnaire created for purposes of this study, return to hospital (Foleys group) prior to planned readmission and not in labour, maternal febrile morbidity, non‐reassuring FHR trace, CS or instrumental delivery for fetal distress, Admission to newborn care, AS 1 and 5 minutes, epidural.
Notes	Setting: Australian metropolitan tertiary teaching hospital, Australia Time period: June 2009 to December 2010 Funding: not reported Declarations of interest: none declared
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number table was performed prior to trial commencement.
Allocation concealment (selection bias)	Low risk	Sealed in sequentially‐numbered, 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	ITT, no missing data reported, no missing cases
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes were reported in results, except secondary outcome 'epidural' (pre specified in trial registration)
Other bias	Low risk	No other bias detected