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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 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
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
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