Orji 2008.
Methods | Randomised controlled trial. Eligible participants who gave informed consent were randomly allocated to either oxytocin or ergometrine group. Allocation was done by opening a sealed envelope from a pack that had been arranged serially. Not blinded. |
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Participants | 600 consenting women in labour with no illnesses or added risk in the active phase at 2 tertiary hospitals in Nigeria. Excluded those with hypertensive disorders of pregnancy, packed cell volume < 30%, history of PPH, haemoglobinopathy, heart disease or caesarean section. |
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Interventions | At delivery of the anterior shoulder: A. oxytocin 10 IU IV (n = 297); B. ergometrine 0.25 mg IV (n = 303). In both groups the third stage of labour was managed actively. Blood loss was measured using a pre‐weighed guaze that was weighed again after delivery. |
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Outcomes | Primary outcomes: PPH (> 500 mL), severe PPH (> 1000 mL). Secondary outcomes: retained placenta, need for blood transfusion, manual placental removal, estimated blood loss (mL), nausea, vomiting, headaches, elevated blood pressure, need for additional uterotonics. |
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Notes | Dates of study: January 2006 to September 2007 Funding sources: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned to previously determined sequence. |
Allocation concealment (selection bias) | Low risk | Quote: "...sealed envelopes arranged serially...". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not mentioned in report assumed not due to different doses of drug being given. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned in report |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data appear to be reported for all participants. No loss to follow‐up reported. |
Selective reporting (reporting bias) | Unclear risk | Protocol unseen but all outcomes pre‐specified in methods text are reported |
Other bias | Unclear risk | No data. |