Salim 2011.
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. |
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Interventions | 1. Foley: (n = 145) 24 F, 60 mL, max 12 hours 2. Double balloon (n = 148), 80/80 mL, max 12 hours |
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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 |
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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 |