Ezeama 2014.
Methods | Randomised double‐blind controlled trial. Participants were randomised using computer‐generated randomisation numbers. | |
Participants | Women admitted to the labour and delivery ward at the Nnamdi Azikiwe University Teaching Hospital in Nnewi, Nigeria between September 2011 and May 2012. Women in labour, without an epidural and anticipating a vaginal delivery were included. Women with the following were excluded: anticipating a caesarean delivery, delivery < 28 weeks, multiple gestation, antepartum haemorrhage, hypertensive disorders, severe anaemia, haemoglobinopathy. |
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Interventions | Immediately after delivery women received: A. oxytocin 10 IU IM (n = 151) or B. ergometrine 0.5 mg IM (n = 149) All received AMTSL including cord traction and uterine massage. Following drug administration, a fresh pad was placed and volume blood loss assessed after 1 hour by weighing of pads and gauze. |
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Outcomes | Primary outcomes: blood loss > 500 mL, occurrence of adverse effects (headache, vomiting, increased diastolic pressure) within 30 minutes of the intervention Secondary: use of additional uterotonics, blood transfusion, evacuation of retained products, manual removal of the placenta, PPH, pre‐ and post‐delivery Hct | |
Notes | Dates of study: September 2011 ‐ May 2012 Funding sources: not reported Declarations of interest: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed using “computer generated randomisation numbers. Quote:” Eligible patients were allocated the “next consecutive randomisation number.” |
Allocation concealment (selection bias) | Low risk | Randomisation was performed using quote: “computer generated randomisation numbers.” Eligible patients were allocated the “next consecutive randomisation number.” Drug ampoules were “placed in opaque sealed envelopes.” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded. Quote: “Person uninvolved with the study prepared the study drugs: 1‐mL ampoules containing either 10 IU oxytocin or 0.5 mg ergometrine. The labels on the ampoules (which were similar in size and color) were removed and the ampoules were placed in opaque sealed envelopes. The study drugs were administered ... by a midwife who was not part of the study.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blinded. See above. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to assess. |
Other bias | Unclear risk | Unclear. |