Lanka 2014.
Methods | RCT | |
Participants | Inclusion: GA > 28 weeks, singletons, intact membranes, absence of labour, cephalic presentation, BS < 5. Exclusion: multifetal gestations, congenital malformations, Gravidity > 4, non‐reassuring FHR trace, ruptured membranes, active genital infection, previous uterine surgery (including CS), low‐lying placenta, chorioamnionitis, EFW > 4000 g, IUFD, known allergies to latex or PGs |
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Interventions | Foley + misoprostol (n = 63): 16F Foley catheter, 30 cc, traction applied, max 12 hours ‐ 25 mcg vaginal misoprostol, every 4 hours up to a max of 8 doses. vaginal misoprostol (n = 63): 25 mcg vaginal misoprostol every 4 hours, with a max of 8 doses |
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Outcomes | induction to delivery interval, rate of vaginal deliveries, hyperstimulation, CS rate, neonatal outcome, chorioamnionitis, oxytocin use | |
Notes | Setting: tertiary care centre, India Study period: 2‐year period Funding: no funding Declarations of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence, block randomisation |
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 | Low risk | ITT analysis, no missing data or cases |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in results |
Other bias | Low risk | No other bias detected |