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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

El Khouly 2017.

Study characteristics
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.
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
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
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