Methods | RCT. | |
Participants | 960 women in Thailand. Inclusion criteria: nulliparous women at or more than 37 weeks’ gestation; spontaneous labour; cephalic presentation; single fetus without fetal distress Exclusion criteria: thick meconium-stained amniotic fluid at admission; contraindications to vaginal delivery or oxytocin augmentation; medical or surgical complications |
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Interventions | Active management group: early amniotomy within 1 hour of admission, and high doses of oxytocin if cervical dilatation was less than 1 cm/hour in the first stage of labour. Initial oxytocin infusion rate was 6 mU/minute and increased by 2 mU/minute every 30 minutes to a maximum rate of 40 mU/minute. Routine care: usual care, no standard protocol, there was variation among obstetricians |
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Outcomes | CS; 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 | Random number table. |
Allocation concealment (selection bias) | Low risk | Numbered, opaque, sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes |
High risk | It was impossible to blind the treatment (active management of labour) to patients |
Blinding of outcome assessment (detection bias) All outcomes |
High risk | The clinician was not blinded to the treatment. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Some post-randomization exclusions (1.5%), but analysis by intention-to-treat |
Selective reporting (reporting bias) | Low risk | Reported on main outcomes. |
Other bias | Unclear risk | The management of the comparison group was not clearly described |