Clinical trial to evaluate broader use of lifesaving, heat-stable medicine for postpartum hemorrhage moves forward

Unitaid welcomes MSD for Mothers* additional financial support for the REACH trial 

A heat-stable medicine that can prevent postpartum hemorrhage (PPH) and is better suited to resource-limited settings may gain broader use, as a clinical trial evaluating its potential to be used as treatment in addition to prevention gets underway.  

Combatting PPH, characterized as severe bleeding after childbirth, is critical to reducing maternal mortality. Though the global maternal mortality rate has declined by 40% between 2000 and 2023, according to a report published Monday, progress has slowed significantly in recent years.  

In 2023, an estimated 260,000 women died from complications in pregnancy or childbirth, nearly all in low- and middle-income countries. PPH is the leading cause of maternal death. In most cases, these deaths could be prevented with accurate diagnosis and timely access to safe, quality-assured, effective medicines. 

Currently, oxytocin is the recommended medicine of choice to prevent and treat PPH. However, oxytocin loses effectiveness if cold chain transportation and storage is not maintained, which can be challenging in low-resource settings. Unlike oxytocin, quality-assured heat-stable carbetocin is a shelf-stable medicine, making it a climate-resilient product that is better suited for use in these health settings.       

However, heat-stable carbetocin is currently only recommended as an alternative to oxytocin for the prevention of PPH. The REACH clinical trial is evaluating its safety and efficacy as treatment. If successful, the trial could expand the approved clinical indication of heat-stable carbetocin and help health systems widely adopt the medicine, accelerating access to quality care for millions of women.  

The trial, which is primarily funded by Unitaid and coordinated by the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), has received additional financing from MSD for Mothers to support full trial implementation. The trial also counts on important in-kind support from HRP and Ferring Pharmaceuticals, the originator of heat-stable carbetocin.  

The REACH trial is part of Unitaid’s nearly US$70 million effort to drive scale up of a package of tools to prevent and treat PPH, including HSC. Anticipating the increased global demand that could arise if the REACH trial has a positive outcome, Unitaid facilitated discussions between the Medicines Patent Pool (MPP) and Ferring Pharmaceuticals to secure a conditional license agreement to enable the additional production and supply of heat-stable carbetocin by more companies once certain criteria, such as purchasing volumes, are met.    

* MSD for Mothers is an initiative of Merck & Co., Inc., Rahway, NJ, U.S.A. For more information, visit www.MSDforMothers.com. 

About Unitaid  

Unitaid saves lives by making new health products available and affordable for people in low- and middle-income countries. Unitaid works with partners to identify innovative treatments, tests, and tools, help tackle the market barriers holding them back, and get them to the people who need them most—fast. Since it was created in 2006, Unitaid has unlocked access to more than 100 groundbreaking health products to help address the world’s greatest health challenges, including HIV, TB, and malaria; women’s and children’s health; and pandemic prevention, preparedness, and response. Every year, these products benefit more than 300 million people. Unitaid is a hosted partnership of the World Health Organization.