| Methods |
2‐arm cluster‐controlled randomised trial |
| Participants |
1586 women were randomised in a community 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 were not specified. |
| Interventions |
10 IU of oxytocin administered IM versus no treatment |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; death. |
| 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 52 CHOs were randomly allocated equally to either the intervention or the control group; this allocation was stratified by both district and distance (#10 km or .10 km) to emergency obstetric care. The randomisation sequence was determined using Stata (version 12) |
| Allocation concealment (selection bias) |
Low risk |
Allocation concealment was not reported but less of an issue in cluster‐randomised trials. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote "The random allocation was not masked". |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Assessors were not blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
Investigators appraised postpartum blood loss by collection with a BRASS‐V calibrated plastic drape placed under the mother, who was asked to remain recumbent for 1 hour following delivery of the baby, or for 2 hours if active bleeding persisted. Quote "Fluids, urine, and faeces were excluded from the blood loss measure by sweeping them to the side and into a receptacle". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote "7 and 9 enrolled women in the oxytocin and control arms, respectively, lacked a blood‐loss measure". |
| Selective reporting (reporting bias) |
Low risk |
The study report matches the study protocol that was registered (ClinicalTrials.gov NCT01108289). |
| 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 Bill and Melinda Gates Foundation (public funding). |
