| Methods |
Randomisation:
double‐blind randomised controlled trial. On admission to labour ward, those women eligible to enter the trial were assigned an opaque, sealed envelope that carried the allocation instructions. Immediately prior to birth, the envelope was opened by the attending midwife and the appropriate numbered vial (with pharmacy coded contents) was kept ready for injection in the third stage of labour.
Sample size calculation:
no sample size calculation was included. |
| Participants |
Inclusions: 2040 women meeting the strict inclusion criteria and who were expected to give birth vaginally were recruited (from a hospital in the United Arab Emirates.
Exclusions: operative delivery (forceps, ventouse, caesarean section), antenatal BP 160/100 mmHg, need for antihypertensive drugs in pregnancy, GA, epidural or diazepam during labour, multiple pregnancy, antenatal anaemia 9 g/dl or less and cardiac disease. |
| Interventions |
Administration of either IM ergometrine‐oxytocin 1 ml (n = 1023) or IM oxytocin 10 iu (n = 1017) with the birth of the anterior shoulder of the baby. |
| Outcomes |
PPH: blood loss equal to or greater than 500 ml, retained placenta, nausea, vomiting, elevation of BP, headache. |
| Notes |
12 women were removed from the trial after randomisation. Further information sought from the authors indicates that the analysis was based on treatment received rather than intention to treat. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
