| Methods |
Randomisation:
double‐blind randomised controlled trial. The trial ampoules were coded by Sandoz, using simple randomisation, with no blocking or prognostic stratification. When the attending midwife deemed a vaginal birth to be imminent, the next available numbered trial ampoule was administered.
Sample size calculation:
it was estimated that if ergometrine‐oxytocin reduced the risk of PPH to 5% from a 'best guess estimate' of 7.5% for oxytocin alone, this would be sufficient to influence the choice of oxytocic in clinical practice. A sample size of at least 3100 women would be required to have an 80% chance of detecting such a difference at the 5% level of statistical significance. |
| Participants |
Inclusions: 3497 women (from 2 metropolitan teaching hospitals in Australia), in whom a vaginal birth was anticipated during the trial period.
Exclusions: planned caesarean section, general anaesthetic given for operative delivery other than caesarean section, antepartum hypertension; maternal refusal; maternal distress; advanced stage in labour; language barrier; fetal abnormality or death in utero; and medical disease. |
| Interventions |
IM ergometrine‐oxytocin 1 ml (n = 1730) or IM oxytocin 10 iu (n = 1753) at time of birth of the anterior shoulder of the baby. |
| Outcomes |
PPH equal to or greater than 500 ml and 1000 ml, manual removal of the placenta, blood transfusion, nausea, vomiting, elevation of blood pressure. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
