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

Salim 2011.

Study characteristics
Methods RCT
Participants Inclusion: viable singleton pregnancy, cephalic presentation, intact membranes, BS of ≤ 6.
Exclusion: contraindication for vaginal delivery, previous caesarean delivery, a low‐lying placenta, fetal malformations that were incompatible with postpartum life, intrauterine fetal death, clinical amnionitis, carriers of hepatitis B/C, HIV, allergy to latex.
Interventions 1. Foley: (n = 145) 24 F, 60 mL, max 12 hours
2. Double balloon (n = 148), 80/80 mL, max 12 hours
Outcomes Time from insertion of the catheter to delivery, mode of delivery, vaginal deliveries within 24 hours, abnormal fetal presentation, cord prolapse, intrapartum fever more than 38°C, bleeding related to catheter insertion, AS.
Notes Setting: Emek medical centre, Afula, Israel. (teaching medical centre)
Study period: June 2008 and December 2010
Funding: Department of obstetrics, Emek medical centre
Declarations of interest: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated numbers, block randomisation
Allocation concealment (selection bias) Low risk Sequentially‐numbered allocation, stored in a box.
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 ITT not reported and not clear if done, 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