Filho 2002.
Study characteristics | ||
Methods | RCT. | |
Participants | Term or post‐term, live, singleton fetus in cephalic presentation, intact membranes, BS < 6, not in labour, medically indicated for labour induction. Exclusion criteria: multiple gestations, non‐cephalic presentation, previous caesarean delivery or uterine scar, rupture of membranes, antepartum bleeding, genital herpes infection, fetal death, placenta previa or previous attempts to induce labour. |
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Interventions | Misoprostol (n = 119): 25 mcg 6‐hourly, max 4 doses. Foley (n = 121): 30cc traction applied 24 hours followed by oxytocin. |
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Outcomes | Induction‐to‐vaginal delivery time, deliveries within 24 hours, mode of delivery, uterine contraction abnormalities, puerperal infection or neonatal outcomes. | |
Notes | Setting: Maternidade Monteiro de Morais, Recife, Brazil Dates of study: between September 2000 and December 2001 Funding sources: financial support from CAPES 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 | Consecutively 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 described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow up, analysis ITT. |
Selective reporting (reporting bias) | Low risk | All pre‐specified data reported. |
Other bias | Low risk | No other bias detected |