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Table 2 Primary and secondary endpoints

From: Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial

Primary endpoints
 The proportion of women:
  • with blood loss of 500 mL or more or the use of additional uterotonics at one hour and up to two hours for women who continue to bleed after one hour;
  • with blood loss of 1,000 mL or more at one hour and up to two hours for women who continue to bleed after one hour.
Secondary endpoints
 The proportion of women:
  • with blood loss of 500 mL or more at one hour (or two hours postpartum if the bleeding continues beyond one hour);
  • receiving additional uterotonics at one hour (or two hours postpartum if the bleeding continues beyond one hour);
  • receiving additional uterotonics up to time of discharge;
  • receiving blood transfusion up to time of discharge;
  • with manual removal of placenta up to time of discharge;
  • having additional surgical procedures (for example, suturing of cervix/high vaginal tear, exploration of uterine cavity under general anaesthetic, uterine compression suture, uterine or hypogastric ligation, hysterectomy) up to time of discharge;
  • with maternal death;
  • with composite outcome of maternal death or severe morbidity (admission to intensive care unit, hysterectomy, blood loss of two litres or more, uterine inversion) up to time of discharge
Blood loss in mL at one hour (or two hours postpartum if the bleeding continues beyond one hour).
The incidence and severity of adverse or serious adverse events up to the time of discharge.
Newborn outcomes (vital status, Apgar score at 5 minutes, resuscitation of the baby, mechanical ventilation).