Methods	RCT.
Participants	111 women. Inclusion criteria: singleton, term pregnancy, cephalic position, intact membranes with a Bishop’s score < 6, with reactive nonstress test, “…attending physician had requested preinduction cervical ripening using the Foley catheter” Exclusion criteria: fetal anomaly or dead fetus, hypertension, vaginal bleeding, ruptured membranes, placenta praevia, IUGR, active herpes infection, without access to phone, without reliable transportation or living more than 30 minutes’ distance from the hospital
Interventions	Both groups had a number 16 Foley catheter inserted into the endocervical canal to or past the internal os; the balloon was filled with 30 ml of sterile water, the end of the catheter was taped to the thigh. After placement of the catheter if there was a reactive nonstress test and no signs of uterine hyperstimulation and the amniotic fluid index was > 5th percentile women were randomised Outpatient group: women received detailed oral and written guidelines on when to seek advice and then were discharged home. 24 hour phone access to a doctor was provided. They were asked to return for review the next morning for induction of labour with oxytocin Inpatient group: women were admitted to the labour ward. They were allowed to ambulate. The catheter was checked every 2-4 hrs and the fetal heart rate was assessed hourly
Outcomes	Primary outcome: Bishop score.
Notes
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer-generated random number table.
Allocation concealment (selection bias)	Low risk	Sequentially numbered envelopes.
Blinding (performance bias and detection bias) Women	High risk	Blinding not attempted.
Blinding (performance bias and detection bias) Clinical staff	High risk
Blinding (performance bias and detection bias) Outcome assessors	High risk
Incomplete outcome data (attrition bias) All outcomes	Low risk	Complete data for main outcomes. Only the outpatient group was followed up in the postnatal period and there was high attrition (40%) for this longer term follow up
Selective reporting (reporting bias)	Unclear risk	Some of the results were difficult to interpret.
Other bias	Unclear risk	Not clear how many of the women approached were eligible for this trial. Not clear how women were managed as regards oxytocin and this may have had an impact on results. Not clear how many women in the outpatient group were surveyed in the postnatal period; figures differ between the main study paper and an abstract reporting survey results

RCT: randomised controlled trial