Methods |
2‐arm active‐controlled randomised trial |
Participants |
510 women 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 women undergoing induction or augmentation of labour or instrumental delivery, or those requiring epidural analgesia or with hypertension in pregnancy, existing hypertension, chronic renal disease, diabetes, vascular diseases, cardiac disease, anticoagulation therapy or allergy to ergometrine or oxytocin. |
Interventions |
500 mcg of ergometrine administered IM versus 10 IU of oxytocin administered by an IV bolus |
Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; blood loss (mL); hypertension. |
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 |
Computer‐generated list of random numbers. |
Allocation concealment (selection bias) |
Unclear risk |
Used numbers that were labelled on envelopes. |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was not reported. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
Objective assessment of blood loss |
Unclear risk |
Methods of appraising blood loss were not reported. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data were collected completely from all randomised study participants. |
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 |
Unclear risk |
Source(s) of funding for the study were not reported. |