Yuen 1995.
Methods | Randomisation: a randomised double blind prospective study. Random allocation by computer‐generated random numbers contained in a consecutively‐labelled sealed envelope. When a women entered the study, a nursing officer not involved in the management of the management of the woman drew up the indicated medication and handed this to the woman's attendants. Sample size calculation: sample size estimation was based on preliminary study which found PPH incidence to be 6% in those given ergometrine‐oxytocin and 12% in those given oxytocin. 1000 women randomised to the study would be sufficient to confirm this observation with a power of 90% at the 5% level of significance. | |
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 | Administration of IM ergometrine‐oxytocin 1 ml (n = 496) or IM oxytocin 10 iu (n = 495) at time of birth of the anterior shoulder of the baby. | |
Outcomes | Blood loss equal to or greater than 500 ml and 1000 ml, delayed haemorrhage, maternal blood pressure retained placenta, manual removal of the placenta, nausea, vomiting, headache antenatal and postpartum haemoglobin. | |
Notes | The study was not analysed on an 'intention‐to‐treat' basis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
BP: blood pressure GA: gestational age IM: intramuscular IU: international units PPH: postpartum haemorrhage