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 |
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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 |
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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