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 |
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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 |
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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 |