Saunders 1989.
Methods | Double blinded randomised controlled trial of oxytocin versus placebo. | |
Participants | 226 Nulliparous women (108 intervention, 118 placebo) with epidural analgesia, 37‐42 weeks' gestation, singleton fetus in vertex presentation, fully dilated cervix, no oxytocin prior to randomisation. | |
Interventions | Oxytocin (initial dose 2 mU/min increasing to maximum of 16 mU/min) versus placebo. | |
Outcomes | Duration of second stage, mode of delivery, postpartum haemorrhage, fetal condition (Apgar scores, neonatal jaundice, nursery admission, cord pH). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as random number allocation although sequencing not specified. |
Allocation concealment (selection bias) | Low risk | Sheffield: infusions of oxytocin added to saline or saline alone were prepared by the pharmacy. London: coded vials of oxytocin or saline alone were used which were added to the infusion by labour ward staff. |
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. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |
Other bias | Low risk | None identified. |