Heat-stable carbetocin, an oxytocin analog, was found to be noninferior to oxytocin for preventing postpartum hemorrhaging associated with vaginal birth, according to research published in the New England Journal of Medicine.
The World Health Organization’s CHAMPION trial was an international randomized, double-blind, noninferiority study that aimed to compare the efficacy of intramuscularly administered heat-stable carbetocin with oxytocin in women following vaginal birth.
The 2 primary outcomes were the fraction of women with ≥500 mL of blood loss or additional uterotonic treatments and the fraction of women with ≥1000 of blood loss.
The investigators included 29,645 expectant mothers who had cervical dilation ≤6 cm and planned to give birth vaginally. Women who did not have a singleton pregnancy or had known allergies to carbetocin, oxytocin homologues, or excipients were excluded from the study. Participants were randomly assigned to receive either an intramuscular injection of heat-stable carbetocin 100 µg or oxytocin 10 IU immediately following vaginal birth.
The percentages of women with blood loss ≥500 mL or requiring use of additional uterotonic treatments for the carbetocin and oxytocin cohorts were 14.5% and 14.4%, respectively (relative risk [RR], 1.01). For women with blood loss ≥1000 mL, percentages in the 2 cohorts were 1.51% and 1.45%, respectively (RR, 1.04). Additional interventions used for bleeding cessation did not vary significantly between the 2 groups.
“The present trial may underestimate the benefit that would be expected with the use of heat-stable carbetocin in low-income and middle-income countries,” the authors discussed. “Within the labor-ward environment, eliminating a need for cold storage will facilitate easier access to the drug for patient care.”
“These data inform care of women in parts of the world where a lack of heat stability is a barrier to the effective prevention of postpartum hemorrhage,” concluded the investigators.
Disclosure: This study was funded by Merck Sharpe & Dohme.
Widmer M, Piaggio G, Nguyen TMH, et al; for the WHO CHAMPION Trial Group. Heat-stable carbetocin versus oxytocin to prevent hemorrhage after vaginal birth [published online June 27, 2018]. N Engl J Med. doi: 10.1056/NEJMoa1805489