| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
450 women were randomised in a hospital setting in Ghana. The population comprised women of unspecified parity, either singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with asthma, epilepsy or contraindications to prostaglandins. |
| Interventions |
10 IU of oxytocin administered IM versus 800 mcg of misoprostol administered rectally |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; death; blood loss (mL); change in Hb; third stage duration (minutes); nausea; vomiting; hypertension; fever; shivering. |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: yes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Sequence generation was not reported. |
| Allocation concealment (selection bias) |
Low risk |
Used sequentially‐numbered, opaque, sealed envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "Unblinding for some participants was possible because the envelopes for women who were initially randomised but who subsequently underwent caesarean section were returned and used for the next women enrolled". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
High risk |
Investigators appraised blood loss by the estimation of attending physicians and midwives. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Estimated blood loss data were unavailable in 9 cases (misoprostol 7; oxytocin 2) and haemoglobin measurements (misoprostol 4; oxytocin 6) were unavailable in 10 cases. |
| 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 Matercare International and the Society of Obstetricians and Gynaecologists of Canada (public funding). |
