Sharma 2015.

Methods	4‐arm RCT, with adequate randomisation (only 2 arms are reported in the poster abstract giving results of the study)
Participants	Setting: India, 2012‐2014 Inclusion criteria: pregnant women, 40 weeks' gestation, single cephalic presentation, 1 previous low segment CS. Postdates (gestation 40 weeks 5 days) Exclusion criteria: described in the study protocol as: interconceptional period less than 18 months, estimated fetal birthweight > 4 kg, poor modified bio‐physical profile (amniotic fluid index), poor dating (not sure of dates, no ultrasonography in first trimester or 2 serial ultrasounds 4 weeks apart in second trimester), premature rupture of membranes/chorioamnionitis, evidence of fetal distress at admission, intrauterine fetal death, any maternal disease, i.e. hypertension, diabetes, renal disease, liver disease, cardiac disease, epilepsy or any chronic medication, any contraindication for vaginal delivery (cephalo‐pelvic disproportion ruled out), type of CS not known (classical or low segment)
Interventions	In the study protocol, the groups are listed as: Comparator: cervical sweeping and stretching at 40 weeks + 5 days Intervention 1: single dose mifepristone (200 mg) orally at 40 weeks + 5 days Intervention 2: single dose mifepristone (400 mg) orally at 40 + 5 Intervention 3: transcervical Foley catheter with 30 mL normal saline inserted at 40 + 5 However, the poster abstract reports intervention 2 versus intervention 3, and does not mention the other 2 arms of the study: Experimental intervention: single dose mifepristone (400 mg) orally at 40 + 5. All women were reassessed 24 h and 48 h later. If BS > 6, amniotomy was done, followed by oxytocin infusion. If after 48 h, BS was < 6, induction of labour was done with oxytocin infusion. Total number randomised: n = 57 Control/comparison intervention: transcervical Foley catheter with 30 mL normal saline inserted at 40 + 5. Total number randomised: n = 50
Outcomes	Spontaneous onset of labour, duration of labour, need and amount of oxytocin required, scar dehiscence, incidence of CS, neonatal outcomes (pH of cord, hypoglycaemia, intensive care unit admission)
Notes	HW contacted the study authors, requesting additional information on the methodology (how blinding was achieved), and results of the 2 arms described in the protocol but not in the published reports. No response was received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as “computer generated randomisation” in the study protocol, not described in the study report
Allocation concealment (selection bias)	Unclear risk	Described as “sequentially numbered, sealed, opaque envelopes” in the study protocol, not described in the study report
Blinding of participants and personnel (performance bias) All outcomes	High risk	Described as “double blind double dummy” in the study protocol, but the description does not fit with having a fake Foley catheter. Not described in the study report
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Described as “double blind double dummy” in the study protocol. Not described in the study report
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	All women recruited appear to be accounted for in the results. However, the omission of 2 arms of the study may suggest bias
Selective reporting (reporting bias)	High risk	The protocol described a 4‐arm study, but only 2 arms were reported in the publication. The brief poster abstract does not report any prespecified neonatal outcomes, and reports only 2‐arms of the 4 comparison groups set out in the protocol
Other bias	High risk	The inconsistencies between the study protocol and published report (such as the omission of 2 arms of the study, information on the methodology, and prespecified outcomes) suggest that this study is at high risk of bias