| Methods |
3‐arm controlled randomised trial |
| Participants |
1964 women were randomised in a hospital setting in Egypt and South Africa. The population comprised women of any parity, either singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with medical complications such as hypertension and diabetes, previous caesarean section, or an abdominal wall that was not thin enough to allow easy palpation of the uterus after delivery. |
| Interventions |
10 IU of oxytocin administered IM versus no treatment |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; severe maternal morbidity: intensive care admissions; additional uterotonics; transfusion; manual removal of placenta. |
| 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 |
Allocated to 1 of 3 groups by selecting the next number in a computer‐generated random number sequence |
| Allocation concealment (selection bias) |
Low risk |
The allocated group was noted inside opaque sealed envelopes |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was not reported. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
In Assiut, investigators appraised blood loss by collection with a calibrated plastic drape placed under the mother within 30 minutes of delivery. At the East London Hospital Complex, investigators appraised blood loss by collection with a low profile plastic “fracture” bedpan placed under the mother. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Investigators were unable to collect outcome data from 14 randomised study participants. |
| Selective reporting (reporting bias) |
Unclear risk |
The study protocol was registered retrospectively (ACTRN: 12609000372280). |
| 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 institution of the authors, or conducted without external funding. |
