Goonewardene 2014.
Methods | RCT | |
Participants | Inclusion: singleton pregnancy, cephalic, cervix unfavourable (MBS < 6), 40 weeks and 6 days Exclusion: multiple pregnancies, malpresentation, previous CS or any contraindication for normal delivery or misoprostol, prior intervention for ripening of the cervix, non‐reactive CTG after fetal acoustic stimulation test. |
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Interventions | Oral misoprostol (n = 74) 25 ug, every 4 hours, max of 2 gifts Foley catheter (n = 78) max 24 hours |
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Outcomes | Modified BS ≥ 6 day 2 after the intervention; Induction to delivery interval, mode of delivery, side effects of misoprostol (only reported in trial register) | |
Notes | Setting: Academic Obstetric Unit, Teaching Hospital, Mahamodara, Galle, India Study period: January 2011 to March 2012 Funding: not reported 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, stratified for parity |
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 | High risk | ITT not mentioned, no FIgure 1, cases excluded for some selective outcomes because of spontaneous labour after intervention, no missing data reported. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in results, except secondary outcome 'side effects misoprostol' not reported. |
Other bias | Low risk | No other bias detected |