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. 2019 Oct 18;2019(10):CD001233. doi: 10.1002/14651858.CD001233.pub3

Goonewardene 2014.

Methods RCT
Participants Inclusion: singleton pregnancy, cephalic, cervix unfavourable (MBS < 6), 40 weeks and 6 days
Exclusion: multiple pregnancies, malpresentation, previous CS or any contraindication for normal delivery or misoprostol, prior intervention for ripening of the cervix, non‐reactive CTG after fetal acoustic stimulation test.
Interventions Oral misoprostol (n = 74) 25 ug, every 4 hours, max of 2 gifts
Foley catheter (n = 78) max 24 hours
Outcomes Modified BS ≥ 6 day 2 after the intervention; Induction to delivery interval, mode of delivery, side effects of misoprostol (only reported in trial register)
Notes Setting: Academic Obstetric Unit, Teaching Hospital, Mahamodara, Galle, India
Study period: January 2011 to March 2012
Funding: not reported
Declarations of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated sequence, block randomisation, stratified for parity
Allocation concealment (selection bias) Low risk Sequentially‐numbered opaque, sealed 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 High risk ITT not mentioned, no FIgure 1, cases excluded for some selective outcomes because of spontaneous labour after intervention, no missing data reported.
Selective reporting (reporting bias) Low risk All pre‐specified outcomes were reported in results, except secondary outcome 'side effects misoprostol' not reported.
Other bias Low risk No other bias detected