Oliveira 2010.
Methods | RCT | |
Participants | Inclusion: singletons in cephalic presentation, GA > 37 weeks, live fetus, BS ≤ 4. Exclusion: ruptured membranes, uterine scar, placenta praevia, chorioamnionitis, EFW > 4000 g, hypersensitivity for products used in intervention |
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Interventions | 1. Foley catheter (n = 80): 14 or 16F, 30 cc, max 48 hours 2. Misoprostol (n = 80) 25 mcg a 6 hours, with a max dose of 200 mcg max 48 hours of induction |
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Outcomes | Oxytocin use, tachysystole, hypertonus of the uterus, BS > 6, total time until cervical modification, delivery route, FHR abnormalities, meconium stained liquor, AS | |
Notes | In Portuguese, but translated Setting: Maternidade Escola de Vila Nova Cachoeirinha, public institution which is administrated by the Secretaria Municipal da Saúde de São Paulo, Brazil Study period:January 2006 to January 2008. Funding: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number sequence. |
Allocation concealment (selection bias) | Low risk | Sequentially‐numbered, sealed, opaque 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 | ITT, no missing data or cases reported |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported in results |
Other bias | Unclear risk | Based on translated article |