Skip to main content
. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

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.
Interventions Misoprostol (n = 119): 25 mcg 6‐hourly, max 4 doses.
Foley (n = 121): 30cc traction applied 24 hours followed by oxytocin.
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
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