El Khouly 2017.
Methods | RCT | |
Participants | Inclusion criteria: singleton pregnancy, cephalic presentation, GA > 28 weeks and the BS < 6. Exclusion criteria: contraindication vaginal delivery, EFW > 4500 g, a previous uterine scar, clinically significant cervical or vaginal infection, chorioamnionitis, unexplained vaginal bleeding, low‐lying placenta, abnormal cervical anatomy or cervical cerclage. |
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Interventions | Foley catheter (n = 36): 18F, 30 mL, max of 12 hours Foley catheter + oxytocin (n = 36): 18F, 30 mL balloon, oxytocin, Foley max of 12 hours) Oxytocin alone (n = 36): increased by 2 mU/minute at 30‐minute intervals until adequate uterine activity was maintained, max dose 32 mU/minute, AROM at 3 cm |
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Outcomes | Duration and dose of required oxytocin, induction to delivery interval, mode of delivery and reason (in case of CS), maternal and neonatal complications | |
Notes | Setting: Menoufia University Hospital, Egypt Study period: between January 2015 and February 2016. 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 | Computer‐generated sequence |
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 | Low risk | Although ITT is not mentioned, figure 1 and results are plausible for ITT, all cases analysed, no missing data described |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in results |
Other bias | Low risk | No other bias detected |