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. 2000 Oct 23;2000(4):CD002862. doi: 10.1002/14651858.CD002862

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