| Methods |
Randomisation:
double‐blind randomised controlled trial. Random allocation, when vaginal birth was imminent, from a sealed consecutively‐numbered opaque envelope, each containing a computer‐generated random number. The preparation and administration of the medication was carried out by a second midwife who was not otherwise involved in the management of the patient. The medical attendant who delivered the baby was not informed of the type of uterotonics used.
Sample size calculation:
sample size estimation was based on the incidence of PPH (> 500 ml) in the participating hospital (where IM ergometrine‐oxytocin is the routine uterotonic drug) being 4% and the incidence of PPH in the Soriano 1996 study (where intravenous oxytocin was used) being 9.7%. A total sample size of 980 participants was estimated as being necessary to detect such a difference with a power of 90% and a Type 1 error of 0.05. |
| Participants |
Inclusions: 991 women having a singleton pregnancy and vaginal birth at a university teaching hospital in Hong Kong. This included women who received oxytocin infusion in the first stage of labour, with this infusion stopped at the end of the second stage of labour.
Exclusions: the presence of medical conditions that precluded the use of ergometrine, (such as pre‐eclampsia and cardiac disease) and conditions that require prophylactic oxytocin infusion after birth (such as grand multiparity ‐ parity = or > 4), presence of uterine fibroids. |
| Interventions |
Allocation to receiving either 1 ml of oxytocin (10 units of oxytocin) intravenously (n = 491) or 1 ml of ergometrine‐oxytocin (5 units of oxytocin and 0.5 mg ergometrine) IM (n = 500). |
| Outcomes |
Blood loss during birth, PPH = or > 500 ml, PPH = or > 1000 ml, need for repeated uterotonics, haemoglobin level before and 24 hours after birth, duration of 3rd stage, need for manual removal of placenta, side‐effects including hypertension, nausea, vomiting, headache and chest pain. |
| Notes |
The injection was given at birth of the anterior shoulder. The placenta was delivered by early clamping of the cord and controlled cord traction.
An additional dose of ergometrine‐oxytocin was given if the uterus was not well contracted after birth of the placenta or if there was excessive vaginal bleeding as assessed by the attendant. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
