| Methods |
2‐arm active‐controlled double‐blinded randomised trial |
| Participants |
3497 women were randomised in a hospital setting in Australia. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing emergency or elective caesarean section, or requiring general anaesthetic for instrumental delivery, or those with hypertension in labour (more than 150/100 mm Hg), antenatal hypertension, maternal distress, advanced stage in labour, language barrier, fetal abnormality, intrauterine death or medical 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; additional uterotonics; transfusion; manual removal of placenta; NNU admissions; breastfeeding; nausea; vomiting. |
| 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 |
The ampoules were numbered by Sandoz by using simple randomisation. There was no blocking or prognostic stratification. |
| Allocation concealment (selection bias) |
Low risk |
The ampoules were numbered by third party (Sandoz). |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Delivery attendants were blinded to treatment allocations. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
High risk |
Investigators appraised blood loss by the estimation of attending obstetricians and midwives. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "All women allocated to receive a drug were included in that group, excluding only the 14 women for whom drug allocation was not recorded". |
| 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 |
High risk |
The study was supported by funding from Sandoz. |
