James 2001.

Study characteristics
Methods	RCT
Participants	Number of women randomised: 74 Setting: Vellore, India Study date: not reported Inclusion criteria Low‐risk women Singleton pregnancy Cephalic presentation GA: 41 completed weeks (287 days) Exclusion criteria Presence of risk factors known to increase perinatal death and morbidity such as chronic hypertension, pre‐eclampsia, maternal diabetes mellitus, fetal growth restriction, multiple gestation, hydramnios, PROM, antepartum haemorrhage and previous caesarean section State of cervix: not mentioned as a criterion
Interventions	Induction group (n = 37): Bishop < 5: cervical ripening with extra‐amniotically placed 16F Foley catheter with 20 mL of saline Bishop > 5: stripping of membranes Then, 12 hours later, IOL by AROM and oxytocin infusion versus EM group (n = 37): daily fetal movement counts; biophysical profile every second day
Outcomes	Mother: mode of birth and indications; duration of labour; mean hospital stay Baby: meconium staining of amniotic fluid; meconium aspiration; Apgar scores < 7 (at 1 and 5 min); need for neonatal intubation; birthweight; birthweight > 4000 g; signs of post‐maturity; perinatal deaths; abnormal electronic fetal trace monitoring
Notes	Funding: not reported Declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A table of random numbers was used.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment was unclear since "... a series of consecutively numbered, sealed envelopes..." was used but no mention was made of opaqueness of the envelopes.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding was not feasible.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinded outcome assessment was not mentioned.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up or post‐randomisation exclusion
Selective reporting (reporting bias)	Unclear risk	All of the outcomes mentioned in the methods section were reported on in the results section; mean duration of labour was reported with no measure of variance. No access to trial protocol to further assess selective reporting
Other bias	Low risk	Appeared to be free of other bias