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 |
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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 |