2018
DOI: 10.1056/nejmoa1805489
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Abstract: Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).

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Cited by 109 publications
(81 citation statements)
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“…In addition, as the price of the uterotonic agent appears to be critical to costing models for lowresource settings (more so than for high-resource setting models), the cost-effectiveness of carbetocin relative to misoprostol will be strongly affected by the supply prices. While the price range across studies included in the review was US $13.10-25.60 per 100μg carbetocin dose, compared with US $0.27-1.56 for a 600μg misoprostol dose, we note that the manufacturer of heat-stable carbetocin has made an in-principle commitment to make the heat-stable formulation of carbetocin available in the public sector of LMICs at an affordable and sustainable price, comparable to the UNFPA price of oxytocin (US $0.27) 30.…”
mentioning
confidence: 82%
“…In addition, as the price of the uterotonic agent appears to be critical to costing models for lowresource settings (more so than for high-resource setting models), the cost-effectiveness of carbetocin relative to misoprostol will be strongly affected by the supply prices. While the price range across studies included in the review was US $13.10-25.60 per 100μg carbetocin dose, compared with US $0.27-1.56 for a 600μg misoprostol dose, we note that the manufacturer of heat-stable carbetocin has made an in-principle commitment to make the heat-stable formulation of carbetocin available in the public sector of LMICs at an affordable and sustainable price, comparable to the UNFPA price of oxytocin (US $0.27) 30.…”
mentioning
confidence: 82%
“…Therefore, the release of the results of the CHAMPION trial, a double‐blind large multicenter trial, which compared the heat‐stable uterotonic, carbetocin, with oxytocin, is exciting because of its potential impact on so many women's lives . This noninferiority trial was designed to demonstrate that carbetocin was not worse than oxytocin in preventing postpartum hemorrhage.…”
Section: Potential New Heat‐stable Drug For Prevention Of Postpartum mentioning
confidence: 99%
“…But this doesn't necessarily translate into any significant difference in clinical efficacy . In the new study, the authors claim oxytocin has “unsatisfactory real-world efficacy as a result of sensitivity to heat.” 1 However, the evidence they cite consists only of assays of the amount of active pharmaceutical ingredient in the vials sampled, 7 not effects on patient outcomes.…”
Section: Clinical Efficacymentioning
confidence: 99%
“…On August 23, 2018, the New England Journal of Medicine published the results of the large, multi-country, World Health Organization (WHO) CHAMPION trial, 1 a non-inferiority study testing carbetocin against synthetic oxytocin for prevention of postpartum hemorrhage. Publication of this trial created some buzz in the international media, with reports in BBC and the New York Times , including quotes from WHO officials claiming that wider use of carbetocin could “revolutionize our ability to keep mothers … alive.” 2 That may be claiming too much.…”
mentioning
confidence: 99%