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. 2014 Jun 19;2014(6):CD003101. doi: 10.1002/14651858.CD003101.pub3

Mahmood 1992.

Methods Randomised by numbered, sealed envelope.
Participants 220 women with SROM.
Inclusion criteria: primigravidae, singleton pregnancies, cephalic presentation, no uterine activity, confirmed SROM.
Exclusion criteria: no significant antepartum haemorrhage, IUGR, diabetes mellitus, rhesus disease, moderate pre‐eclampsia, history of venereal disease, temperature of > 37.5C, ruptured membranes > 12 hours or meconium‐stained amniotic fluid on admission.
Interventions 2 mg PGE2 vaginal gel (n = 110) with a repeat treatment of 1 mg PGE2 gel at 6 hours if no uterine activity. Oxytocin administered 24 hours after admission if labour had not begun.
Conservative group (n = 110) received oxytocin at 24 hours after admission if labour did not ensue.
Outcomes Time from admission to onset of labour or delivery, mode of delivery, oxytocin augmentation, epidural anaesthesia, maternal side‐effects, maternal and neonatal infection rates, Apgar scores at 1 and 5 minutes, NICU admission rates.
Notes Aberdeen Maternity Hospital, Scotland, UK.
January 1988 to May 1990.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of random sequence generation not reported.
Allocation concealment (selection bias) Unclear risk Numbered, sealed envelopes, not stated if opaque.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No randomised patients lost to follow‐up.
Selective reporting (reporting bias) Unclear risk Unclear which outcomes prespecified.
Other bias Unclear risk Single centre RCT.