Methods |
2‐arm active‐controlled randomised trial. |
Participants |
Between January 2006 and September 2007, 600 parturients were randomised in a hospital setting in Nigeria. The population comprised women of parity 6 or less, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised parturients undergoing caesarean section, or those with hypertension in pregnancy, packed cell volume less than 30%, previous PPH, haemoglobinopathy or cardiac disorder. |
Interventions |
10 IU of oxytocin administered by an intravenous bolus (n = 297) versus 250 mcg of ergometrine administered by an intravenous bolus (n = 303). |
Outcomes |
The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, manual removal of placenta, blood loss (mL), change in Hb level, third‐stage duration (min), nausea, vomiting, hypertension, headache. |
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) |
Unclear risk |
Randomisation sequence generation was not reported. |
Allocation concealment (selection bias) |
Unclear risk |
Allocation was done by sealed sequentially‐numbered 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 |
Investigators evaluated blood loss by "using a pre‐weighed gauze that was weighed again after delivery." |
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, but not all of the outcomes projected by methodological descriptions were reported as results in the study report (cases of transfusion and PPH at least 1000 mL were omitted). |
Intention to treat analysis |
Unclear risk |
The authors did not specify whether 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. |