Delhi : Globally, about 800 women die every day of preventable causes related to pregnancy and childbirth; 20 per cent of these women are from India,1 and Postpartum Haemorrhage (PPH) is the leading cause of maternal mortality in India
Ferring Pharmaceuticals and MSD, known as Merck & Co., Inc., Kenilworth, N.J., U.S.A., through its MSD for Mothers initiative, today announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention),a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO). CHAMPION is investigating whether Ferring’s proprietary and heat-stable carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum haemorrhage PPH).2,3 Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH.2,3
While one of India’s millennium development goals (MDG) was to reduce its Maternal Mortality Ratio by three quarters, India did not reach this goal and its MMR stands at 167 and haemorrhages and infections still continue to be the leading causes.This situation may now change, thanks to a large trial (The CHAMPION trial) undertaken by the Human Reproduction Program (HRP) at the World Health Organization enrolling nearly 30,000 women in 10 countries including India, wherein the effectiveness and safety of heat-stable carbetocin vs. oxytocin, the current standard of care, for preventing PPH after vaginal birth was compared.
According to SRS 2001-2003, PPH(post-partum haemorrhage)for which the above-mentioned drug is used, accounts 38 percent of maternal deaths. PPH is a frequent complication of delivery and its reported incidence in India is 2% – 4% after vaginal delivery and 6% after cesarean section with uterine atony being the most common cause (50%).
Various studies in different regions of India report different prevalence of PPH4,5.
North east region: 21.27%
Western India: 24.6%
The CHAMPION trial compares the effectiveness and safety of Ferring’s Heat-stable carbetocin versus the current standard of care, oxytocin, for preventing PPH after vaginal birth.2,3 Heat-stable carbetocin would address a significant limitation associated with oxytocin –the need for refrigeration during shipping and storage to prevent degradation in temperatures above 8°C.3,Heat-stable carbetocin may remain active long-term in hot and humid climates,3 and could potentially reduce the incidence of PPH in areas where cold storage is difficult to achieve and maintain,3,4 and where 99% of maternal deaths due to PPH currently occur.4
“Using our established expertise in Reproductive Medicine and Women’s Health, we strive to find innovative treatments that will help to dramatically reduce the number of mothers dying as a result of childbirth,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “Our heat-stable carbetocin is just one example of this research effort and forms part of our ongoing commitment to safeguarding the health of families worldwide. We are looking forward to seeing the results from the CHAMPION trial and hope that the learning will usher in a new era in the prevention of PPH.”
If the results of the CHAMPION trial are favourable, Ferring will seek registration of heat-stable carbetocin on a broad basis around the world. If approved, Ferring would manufacture the product and it would be provided to the public sector of low- and lower-middle-income countries at an affordable and sustainable access price. Results from the trial are expected to be presented and published during the second half of 2018.
“The CHAMPION trial has the potential to change the paradigm in how we save more mothers from dying during childbirth,” said Julie L. Gerberding, M.D., M.P.H. Executive Vice President & Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health at MSD. “Along with our partners, we recognized that heat-stable carbetocin could be a transformative solution to preventing PPH, which is the number one cause of maternal mortality. Through MSD for Mothers, we provided our company’s scientific expertise and financial resources to prove the concept and ultimately make a sustainable impact on the health of mothers, families and communities.”