Methods |
3‐arm active‐controlled randomised trial. |
Participants |
Between dates unspecified, 144 parturients were randomised in a hospital setting in Nigeria. 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 parturients undergoing instrumental delivery, or those with previous PPH, multiple pregnancy, polyhydramnios or vaginal lacerations. |
Interventions |
200 mcg or 500 mcg of ergometrine administered intramuscularly (n = 96) versus 500 mcg plus 5 IU of ergometrine plus oxytocin administered intramuscularly (n = 48). |
Outcomes |
The study recorded the following outcomes: PPH at 500, manual removal of placenta, blood loss (mL). |
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) |
Unclear risk |
Investigators performed restricted random allocation. |
Allocation concealment (selection bias) |
Unclear risk |
Investigators used sealed sequentially‐numbered envelopes. |
Blinding of participants and personnel (performance bias) All outcomes |
Unclear risk |
"The identity of the various drugs was not known to the investigators until after completion of the trial." |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Assessor blinding was not reported. |
Objective assessment of blood loss |
High risk |
Investigators evaluated blood loss by collection in a dish pressed against the vulva for 3 minutes: the contents were carefully measured. |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
The study authors did not mention any incomplete outcome data. |
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. |