Mahmood 1995.
Methods | Numbered, sealed opaque envelopes with allocation from table of random numbers. | |
Participants | 260 women with singleton uncomplicated pregnancy, cephalic presentation, favourable cervix (Bishop's score 6 or more) | |
Interventions | 2 groups: Amniotomy alone ‐ reviewed in 4 hours and oxytocin infusion commenced if not contracting or no cervical change. Vaginal prostaglandin E2 gel (primips 2 mg, multips 1 mg) ‐ reviewed at 4 hours for amniotomy or sooner if requested analgesia or if spontaneous ROM. Oxytocin infusion 2 hours later if uterine activity not established. | |
Outcomes | Primary: uterine hyperstimulation with FHR changes; caesarean section. Secondary: oxytocin augmentation; uterine hyperstimulation without FHR changes; epidural analgesia; instrumental vaginal delivery; meconium stained liquor; neonatal intensive care admission; perinatal death; maternal side effects (intrapartum pyrexia), postpartum haemorrhage. Not prespecified: antibiotics to baby. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
IUGR: intrauterine growth retardation ROM: rupture of membranes FHR: fetal heart rate SD: standard deviation