Methods | Randomization was accomplished by alternating women to aggressive management or control groups | |
Participants | 150 women (n = 75 in each group). Inclusion criteria: 37-42 weeks’ gestation; uterine contractions accompanied by cervical dilatation of 3 cm or ruptured membranes; less than 3 contractions lasting 40 seconds each in a 10-minute time period |
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Interventions | Early aggressive management: amniotomy if required, and oxytocin infusion. This was accomplished within 30 minutes of the admission. Initial oxytocin infusion rate:1 mU/ minute and increased by 1 mU/minute every 30 minutes until adequate contraction pattern was achieved. Control group: usual care. |
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Outcomes | Maternal characteristics; cervical dilatation; effacement %; caesarean delivery; instrumental and spontaneous vaginal deliveries; duration of labour; Apgar score at 1 and 5 minutes; cord pH; birthweight | |
Notes | Prevention trial. Nulliparous women. | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quasi-randomization by alternating women. |
Allocation concealment (selection bias) | High risk | The women were allocated by alternate assignment. |
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 | No information on numbers of postpartum women followed up. |
Selective reporting (reporting bias) | Low risk | Main outcomes reported. |
Other bias | Unclear risk | No information on eligible women. |