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. Author manuscript; available in PMC: 2014 Sep 11.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Sep 12;9:CD006794. doi: 10.1002/14651858.CD006794.pub3
Methods RCT.
Participants 448 women in Nigeria.
Inclusion criteria: nulliparous women in spontaneous labour, single fetus with cephalic presentation at term
Exclusion criteria: contraindications to vaginal delivery or oxytocin augmentation, pregnancy or medical complications
Interventions Active management group: early amniotomy was performed when labour was diagnosed, high doses of oxytocin if cervical dilatation was less than 1 cm/hour in the first stage of labour or descent was not demonstrated for 1 hour or more in second stage. Initial oxytocin infusion rate was 6mU/minute and increased by 6 mU/minute every 15 minutes to a maximum rate of 36 mU/minutes, separate labour room cared for by a nurse-midwife.
Routine care: usual care, no standard protocol, there was variation among obstetricians
Outcomes Mode of delivery; duration of labour; maternal complications and neonatal outcomes
Notes Prevention trial. Nulliparous women.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer-generated random schedule.
Allocation concealment (selection bias) Low risk Opaque, sealed envelopes.
Blinding of participants and personnel (performance bias)
All outcomes
High risk The participants were not blinded to the treatment.
Blinding of outcome assessment (detection bias)
All outcomes
High risk The clinicians were not blinded to the treatment.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk Some post-randomization exclusions (11.7%).
Selective reporting (reporting bias) Low risk Main outcomes were reported.
Other bias Unclear risk Number of women eligible for recruitment were not shown.

CS: caesarean section

RCT: randomized controlled trial