Methods |
Double blinded randomised controlled trial of oxytocin versus placebo. |
Participants |
93 Nulliparous women (46 intervention, 47 placebo) with epidural analgesia, > 35 weeks' gestation, singleton fetus in vertex presentation, 6 cm dilated or less. |
Interventions |
Artificial rupture of membranes and oxytocin (initial dose 2 mU/min increasing to maximum of 32 mU/min) versus placebo. |
Outcomes |
Duration of first and second stage, mode of delivery, postpartum haemorrhage, fetal condition (Apgar scores, intubation, nursery admission, cord pH). |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Table of random numbers. |
Allocation concealment (selection bias) |
Low risk |
Coded ampoules of oxytocin or saline were prepared by pharmacy. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All data accounted for. |
Selective reporting (reporting bias) |
Unclear risk |
This cannot be assessed as there was no published protocol or trial registration. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double blinded, unless slow progress noted and code was broken. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not stated. |
Other bias |
Low risk |
None identified |