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. |
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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 |
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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 |
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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 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 |