Sciscione 2001.

Study characteristics
Methods	RCT
Participants	Inclusion criteria Singleton, term pregnancy, cephalic position, intact membranes with a BS < 6, with reactive nonstress test, quote: "...attending physician had requested pre‐induction cervical ripening using the Foley catheter" 111 women randomised and analysed. 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	Intervention: home IOL with Foley catheter 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. 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 IOL with oxytocin. Total number randomised to this group: N = 61 Comparator: inpatient IOL with Foley catheter 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. Women were admitted to the labour ward. They were allowed to ambulate. The catheter was checked every 2 to 4 hours and the fetal heart rate was assessed hourly. Total number randomised to this group: N = 50 Comparison and subgroups Comparison: 3, IOL with Foley catheter Subgroup by parity: S3 ‐ mixed Subgroup by membrane status: S1 ‐ intact membranes Subgroup by cervical status: S1 ‐ unfavourable Subgroup by indication for induction: S3 ‐ mixed
Outcomes	Primary outcome: Bishop score.
Notes	Trial setting: 2 tertiary hospitals, Christiana Hospital (Delaware) or Thomas Jefferson University Hospital (Pennsylvania), in USA. Trial dates: May 1998 to December 1999. Sources of trial funding: not mentioned in the trial report Trial authors' declarations of interest: not mentioned in the trial report Additional information:
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "...computer‐generated random number table.."
Allocation concealment (selection bias)	Unclear risk	Sequentially numbered envelopes, but not described as 'opaque'
Blinding of participants and personnel (performance bias) All outcomes	High risk	It is not possible to blind participants and personnel to the location, and this may have influenced subjective outcomes although not objective outcomes.
Blinding of outcome assessment (detection bias) All outcomes	High risk	No mention as to whether outcome assessor was blinded so most likely not as it takes considerable effort.
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	Outcomes listed in methods seem to all be reported in results, but we did not assess the trial protocol.
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.