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. |