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. 2019 Oct 18;2019(10):CD001233. doi: 10.1002/14651858.CD001233.pub3

Kuppulakshmi 2016.

Methods RCT
Participants Not mentioned
Interventions intracervical dinoprostone (n = 100): 0.5 mg, 6‐hourly, max 2 doses
Foley catheter (n = 100), 30 mL, max 12 hours in place.
Outcomes Vaginal delivery within 24 hours, improvement in BS, induction to onset of active labour and induction to delivery interval, mode of delivery, occurrence of maternal complications and fetal outcome, cost‐effectiveness
Notes Setting: India
Study period: June 2015 ‐ July 2016
Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Only described that patients were randomly allocated
Allocation concealment (selection bias) Unclear risk Only described that patients were randomly allocated
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 Unclear risk No missing data described, difficult to judge how selection of patients was done, if there was ITT, if patients were excluded. no numbers of analysed patient in result section
Selective reporting (reporting bias) Low risk Pre specified outcomes reported in method section were all reported
Other bias Low risk No other bias detected