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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Lanka 2014.

Study characteristics
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
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
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
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