Skip to main content
. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Chavakula 2015.

Study characteristics
Methods RCT
Participants Inclusion: singleton, cephalic, fetal growth restriction, ≥ 34 weeks.
Exclusion: previous caesarean deliveries, uterine surgery, a multiple pregnancy, ruptured membranes, a BS > 6, severe fetal growth restriction, abnormal FHR prior to induction, pre‐partum haemorrhage.
Interventions 1. Foley catheter (n = 54) 16F, 30 mL, catheter was removed after 12 hours.
2. Vaginal misoprostol (n = 46) every 6 hours, 25 mcg, max 3 doses
Outcomes Hyperstimulation with FHR changes, BS at AROM, duration of induction to delivery, vaginal delivery within 12 hours and 24 hours, CS, oxytocin, chorioamnionitis, antibiotics, NICU admission, AS < 7 at 5 minutes, patients and caregiver satisfaction (VAS score)
Notes Setting: tertiary care teaching hospital in South India with approximately 13,000 deliveries per year.
Study period:December 2011 to June 2012.
Funding: not stated
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 stated
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