Meetei 2015.
| Study characteristics | ||
| Methods | RCT | |
| Participants | Inclusion: 1 previous low transverse CS, singleton live pregnancy, cephalic presentation, > 28 weeks and BS < 5. Exclusion: previous classical or T‐shaped incision, unknown scar, transfundal uterine surgery, medical or obstetric complications that preclude vaginal delivery, placenta previa, low‐lying placenta undiagnosed vaginal bleeding, maternal heart disease, rupture of membranes, interval between previous CS and present pregnancy/conception < 6 months, cervico‐vaginal infection, unclean vaginal examination, infection in previous CS |
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| Interventions | 1. Foley catheter (n = 30): 16F, 30 mL balloon, max 12 hours, thereafter start of oxytocin augmentation 2. Oxytocin (n = 30): 1 mUh/minute, after 1 hour 2/mUh/minute, after 1 hour 4 mUh/minute (max 12 hours). oxytocin augmentation as above |
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| Outcomes | Change in BS before and after 12 hours of ripening, percentage and time interval of spontaneous labour, insertion and expulsion interval of Foley catheter, route of delivery/outcome of delivery, time required from the beginning of cervical ripening to delivery, hyperstimulation, fetal distress, scar dehiscence, uterine rupture | |
| Notes | Setting: Department of Obstetrics and Gynecology, PGIMER, Chandigarh, India Study period: July 2004 and November 2005, Funding: no funding 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 | Randomisation by Tippet's table |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| 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 | Analysing method not reported and not clear, 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 |