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. |
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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. |
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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. |
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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. |