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. 2009 Oct 7;2009(4):CD003246. doi: 10.1002/14651858.CD003246.pub2

Hannah 1996.

Methods RCT.
Participants 5041 women. PROM, GA > 37 wks, singleton, cephalic, no recent attempt at induction of labour.
Interventions IV oxytocin, immediate 
 vs 
 vaginal PGE2 q6h x 2, then IV oxytocin if still not in labour 
 vs 
 expectant management x 96 hrs, IV oxytocin if still not in labour 
 vs 
 expectant management x 96 hrs, vaginal PGE2 as above if still not in labour.
Outcomes C/S, perinatal death, uterine hyperstimulation, uterine rupture, epidural analgesia, instrumental vaginal delivery, meconium‐stained liquor, Apgar < 7 at 5 minutes, admission to NICU, maternal vomiting, maternal diarrhea, postpartum haemorrhage, women not satisfied, chorioamnionitis, maternal antibiotics, endometritis, neonatal infection, fetal distress. (Maternal satisfaction; we have included in the analysis the number of women saying there was nothing about the induction method that they liked.)
Notes Computer randomisation program. Allocation concealment by touch‐tone telephone access.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk Computer‐randomisation program.
Allocation concealment? Low risk  
Blinding? 
 Women High risk  
Blinding? 
 clinical staff High risk  
Blinding? 
 outcome assessor Unclear risk Assessors blinded for some outcomes.