| Methods |
Randomisation:
a double‐blind randomised controlled trial. Sandoz Products prepared the trial ampoules, giving them unique numbers and the code was not broken until after completion of the study. Simple randomisation was used, with no blocking or stratification. During the second stage of labour, when it was clear a birth would be vaginal, women who had consented to participate were allocated the next available ampoule.
Sample size calculation:
No prior power calculations were carried out. The study was aimed at recruiting as many women as possible during a 6‐month period during 1984. |
| Participants |
Inclusions: 461 women giving birth at the Hope Hospital in Salford, UK over the study period were recruited.
Exclusions: women for whom a caesarean section was planned, or who had significant hypertension or cardiac disease. |
| Interventions |
Random allocation to either IM ergometrine‐oxytocin 1 ml (n = 230) or IM oxytocin 5 iu (n = 231) at the time of birth of the anterior shoulder of the baby. |
| Outcomes |
Postpartum blood loss, the length of the third stage of labour and manual removal of placenta. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
