| Methods |
2‐arm active‐controlled double‐blinded randomised trial |
| Participants |
1000 women were randomised in a hospital setting in Hong Kong. The population comprised women of unspecified parity, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women requiring oxytocin infusion in the third stage, or those with pre‐eclampsia or cardiac disorder. |
| Interventions |
500 mcg plus 5 IU of ergometrine plus oxytocin administered IM versus 10 IU of oxytocin administered IM |
| 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; death; change in Hb; nausea; vomiting; headache. |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Used computer‐generated random numbers. |
| Allocation concealment (selection bias) |
Unclear risk |
Used sequentially‐numbered, opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "When a patient entered the study, a nursing officer who was not involved in the management of the patient drew up the indicated medication and handed this to the patient’s attendants". Study participants and caregivers were thus blinded to treatment allocations until the codes were revealed after all data were collected in the study. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
Unclear risk |
Investigators appraised blood loss during delivery quote: "by measuring the amount of blood clots and weighing the towels used". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "9 [randomised participants] were excluded: 3 had a twin pregnancy, 1 had blood transfusion during labour, and the other 5 had unavailable records". |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
High risk |
Not all study participants were included in the analysis. |
| Funding source |
Unclear risk |
Source(s) of funding for the study were not reported. |
