Mundle 2017.

Methods	RCT
Participants	Inclusion: age ≥ 18 years, ≥ 20 weeks’ gestation or later with a live fetus, decision made to induce vaginal birth because of pre‐eclampsia or hypertension Exclusion: unable to give informed consent, previous CS, multiple pregnancy, ruptured membranes, chorioamnionitis, allergy to misoprostol.
Interventions	1. Foley catheter (n = 300): 18F, 30 mL balloon, traction applied, max 12 hours, afterward start oxytocin or AROM 2. Oral misoprostol (n = 302) 25 mcg, 2‐hourly, max of 12 dose (24 hours). In primigravid women the dose could be increased to 50 mcg 2‐hourly after the first 2 doses oxytocin administered through gravity infusion set
Outcomes	Vaginal birth within 24 hours, induction to birth interval (vaginal births, CSs, and all births), vaginal births within 12 hours, cervix unchanged at 12 hours and 24 hours, need for oxytocin augmentation, time from randomisation to start of induction and birth, total dose of misoprostol used and the number of participants given a 50 μg dose. Maternal complications, satisfaction, fetal/neonatal complications
Notes	Fetal surveillance with doptone Setting: 2 public hospitals in Nagpur, India Study period: December 2013 to June 2015 Funding: Department for International Development, Medical Research Council, and Wellcome Trust Joint Global Health Trials Scheme. The funder of the study had no role in data collection Declarations of interest: ADW is a scientific adviser to Azanta, a Danish pharmaceutical company, MAT has provided consultancy services to Chiesi, Bristol–Myers Squibb, Novartis, Shire, Janssen, and Grunenthal. both authors received no personal payment,
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated pseudo‐random numbers, block randomisation, stratified by centre
Allocation concealment (selection bias)	Low risk	Sequentially‐numbered, sealed, 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, missing data reported, but small numbers and not in outcomes of interest for this review, no cases missing
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes were reported in results
Other bias	Low risk	No other bias detected