Primary outcome
blood loss, tachycardia, low systolic blood pressure, PPH
BLOOD LOSS, EVENT, HAEMODYNAMIC INSTABILITY
The primary outcome is a clinical diagnosis of primary PPH. This may be an estimated blood loss of more than 500 ml in vaginal birth or more than 1000 ml in caesarean birth or any blood loss sufficient to compromise haemodynamic stability within 24 h of birth. Haemodynamic instability is based on clinical judgement and assessed using clinical signs (low systolic blood pressure, tachycardia, reduced urine output). The total estimated blood loss at the time of PPH diagnosis and presumed cause(s) of PPH will be recorded.The true event rate of the primary outcome in the trial population is unknown. Interim analyses may indicate a lower-than-expected event rate, or new information may emerge that alters assumptions about the treatment effect, affecting the power of the study. To ensure the study has adequate power, prior to unblinding we will allow the primary outcome to be changed, with any changes set out in a statistical analysis plan.