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. |