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

Deo 2012.

Methods RCT
Participants Inclusion: full‐term singleton gestation, cephalic presentation, indication for IOL. BS < 6.
 Exclusion: rupture of membranes, antepartum bleeding, placenta praevia, previous induction or pre‐induction agent during the pregnancy.
Interventions Foley catheter (n = 50): 16 F with 30 mL balloon, traction applied. no max hours described.
 Misoprostol vaginal (n = 54): 25 ug post fornix, every 4 hours max 8 doses.
Dinoprostone vaginal gel (n = 52), 2 mg, once every 6 hours, max of 3 doses
Outcomes Change in BS, total time for induction, delivery route, uterine tachysystole (defined as 6 contractions in 10 minutes, in 2 consecutive 10 minutes periods), uterine hypertonus (contraction lasting longer than 3 minutes), subject comfort as women were asked to evaluate their discomfort on a visual scale from 0 to 10.
Notes Setting: CSM Medical University (India).
Study period: not reported, 1 year duration
Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random allocation numbers
Allocation concealment (selection bias) Low risk Consecutive, 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 High risk As treated analysis (2 or 4 exclusions? (158 cases analysed, but total of included patients makes 156)
Primary outcome: unclear how many women in Foley were analysed, in comparison groups 4 cases missing without explanation
Selective reporting (reporting bias) Low risk All pre‐specified outcomes were reported in results
Other bias Low risk No other bias detected