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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 Randomization was based on the woman’s medical file number (odd or even numbers)
Participants 145 women (n = 75 in the active labour management group, n = 70 in the traditional labour management (controls) group)
Interventions Active management group: amniotomy was performed and oxytocin given as soon as cervical dilatation was less than 1 cm/hour for the first 3 hours of labour.
Traditional management group: routine care.
Initial oxytocin infusion rate in both groups: 5 mU/minute and increased every 15 minutes up to a maximum rate of40 mU/minute. It was decreased if signs of fetal distress or uterine contractions < 2 minutes apart were present
Outcomes Mode of delivery; epidural; Apgar < = 6 at 1 minute and 5 minutes; length of labour; meconium; neonatal and maternal morbidity
Notes Prevention trial. Nulliparous women.
Article written in Spanish.
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) High risk Last digit hospital record number.
Allocation concealment (selection bias) High risk The method of allocation was based on the woman’s medical file number (odd or even numbers)
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
Low risk No post-randomization exclusions.
Selective reporting (reporting bias) Low risk Main outcomes reported.
Other bias Unclear risk No information on the number of eligible women.