Culver 2004.

Study characteristics
Methods	RCT, computer‐generated block randomisation 4 and 6, consecutively numbered envelopes.
Participants	Nulliparous women GA 28 or more weeks, BS < 6, intact membranes, singleton, cephalic presentation, Exclusion: previous uterine surgery, non‐reassuring FHR, latex allergy, contraindication to vaginal birth.
Interventions	Foley 30 cc + concurrent oxytocin (83 patients analysed). Misoprostol 25 mcg intravaginally 4‐hourly, oxytocin augmentation after ripening. (79 patients analysed.)
Outcomes	Primary: CS Secondary: tachysystole, hyperstimulation, abnormal FHR tracing, intrapartum and postpartum fever, use of antibiotics, estimated blood loss, blood transfusions, AS, neonatal resuscitation, admission to ICU, meconium aspiration, sepsis, death.
Notes	Power analysis showed 266 patients were to be included, 173 were randomised. Study was stopped because principle investigator moved to other hospital. 11 patients were excluded from analysis, either received other treatment, or incomplete data. Setting: North Caroline Women's hospital and WakeMed hospital, North Carolina, USA Study period: June 1999 to April 2001 Funding: not reported Declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated sequence.
Allocation concealment (selection bias)	Low risk	Consecutively numbered 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 described
Incomplete outcome data (attrition bias) All outcomes	Low risk	9 patients had incomplete records (4 and 5 in both groups), they were excluded. 2 patients (1 in every group) who did not receive the treatment were excluded, but otherwise ITT.
Selective reporting (reporting bias)	Low risk	All pre‐specified outcome measures are reported.
Other bias	High risk	Recruitment goal was not reached, because PI moved to another institution.