| Methods |
2‐arm controlled randomised trial |
| Participants |
1512 women were randomised in a hospital setting in the UK. The population comprised women of parity 5 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing augmentation of labour or instrumental delivery or requiring epidural analgesia, or those with placenta praevia, previous PPH, antepartum haemorrhage, Hb less than 100 g/L or mean corpuscular volume less than 75 fL, non‐cephalic presentation, multiple pregnancy, intrauterine death, grand multiparity (more than 5), fibroids, anticoagulation therapy, pre‐term labour (less than 32 weeks) or contraindications to any of the drugs. |
| Interventions |
Unspecified of ergometrine plus oxytocin administered IM versus no treatment |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; blood loss (mL); third stage duration (minute); NNU admissions; breastfeeding; nausea; vomiting; headache; maternal satisfaction. |
| Notes |
Contact with study authors for additional information: no. Additional data from authors: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The randomisation schedule used variably sized balanced blocks, and the randomisation envelopes were prepared in advance in the National Perinatal Epidemiology Unit (NEPU). |
| Allocation concealment (selection bias) |
Low risk |
Used sequentially‐numbered, opaque, sealed envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Study participants and caregivers were not blinded to treatment allocations. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Assessors were not blinded to treatment allocations. |
| Objective assessment of blood loss |
High risk |
Investigators appraised blood loss by the estimation of attending midwives. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Blood loss data were collected completely from all randomised study participants. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
Low risk |
All those who were enrolled and randomly allocated to treatment were included in the analysis, in the groups to which they were randomised. |
| Funding source |
Low risk |
The study was supported by funding from the Public Health and Operational Research Committee of the Anglia and Oxford Regional Health Authority, UK (public funding). |
