The primary outcome of the trial was the incidence of postpartum haemorrhage, defined by a blood loss of ≥500 mL, measured with a graduated collector bag.25 (link) The main secondary outcomes were other objective measures of postpartum bleeding: measured blood loss ≥1000 mL at bag removal, mean measured blood loss at 15 minutes after birth (the bag had to be left in place at least 15 minutes to have one measure of blood loss at the same time point in all women), mean measured postpartum blood loss at bag removal, and mean changes in peripartum haemoglobin level and haematocrit (difference between haemoglobin level and haematocrit before delivery and at day 2 postpartum). Other secondary outcomes included use of supplementary uterotonic treatment; postpartum transfusion (until discharge); arterial embolisation or emergency surgery for postpartum haemorrhage; other characteristics of the third stage, including duration, manual removal of the placenta; and women’s experience of the third stage, assessed by a self administered questionnaire on day 2 postpartum. Safety outcomes included uterine inversion, cord rupture, and pain.
The detail of procedures used to manage the third stage, as well as all clinical outcomes identified during the immediate postpartum period, were prospectively collected by the midwife or obstetrician in charge of the delivery and recorded in the woman’s electronic form in the labour room. Other data were collected by a research assistant, independent of the local medical team. An independent data monitoring committee, which met monthly, was responsible for reviewing adherence to the trial procedures, recruitment, and safety data; the quality of collected outcome data was checked in each centre for 10% of the included women, randomly selected, and in all cases of postpartum haemorrhage.
The detail of procedures used to manage the third stage, as well as all clinical outcomes identified during the immediate postpartum period, were prospectively collected by the midwife or obstetrician in charge of the delivery and recorded in the woman’s electronic form in the labour room. Other data were collected by a research assistant, independent of the local medical team. An independent data monitoring committee, which met monthly, was responsible for reviewing adherence to the trial procedures, recruitment, and safety data; the quality of collected outcome data was checked in each centre for 10% of the included women, randomly selected, and in all cases of postpartum haemorrhage.
