Completion of Largest Clinical Trial Ever Conducted in Postpartum Haemorrhage

Each year, according to medical experts,14 million mothers are affected by PPH. It is said to be the leading direct cause of maternal mortality. Between 2003 to 2009, according to a Ferring Pharmaceuticals publication, 480,000 mothers died from PPH. They say that even when women survive, PPH can result in the need for serious medical interventions, including surgical removal of the uterus (hysterectomy) as well as blood transfusions to address severe anaemia.
Postpartum bleeding or postpartum hemorrhage (PPH) is often defined as the loss of more than 500 ml or 1,000 ml of blood within the first 24 hours following childbirth. Signs and symptoms may initially include: an increased heart rate,feeling faint upon standing and an increased breath rate. As more blood is lost the women may feel cold, their blood pressure may drop, and they may become restless or unconscious. The condition can occur up to six weeks following delivery.

The most common cause is poor contraction of the uterus following
childbirth.Not all the placenta being delivered, a tear of the uterus, or poor blood clotting are other possible causes.
By preventing PPH from ever occurring, heat-stable carbetocin, a drug whose clinical trails has just been concluded,has the potential to both save lives and avoid severe, dangerous and costly long-term side effects.
“Despite progress towards the UN Sustainable Development Goal of reducing maternal mortality, every single day women across the world are dying unnecessarily from childbirth complications such as PPH. Timely administration of effective medicines can avoid the maternal deaths that occur due to excessive bleeding after childbirth,” said Mariana Widmer, Technical Officer, Maternal and Perinatal Health, WHO. She noted that “If the results of the trial for heat-stable carbetocin are favourable, this collaboration between private life sciences and the global public health community could help save women’s lives worldwide.”

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. Heat-stable carbetocin could address a significant limitation associated with oxytocin – the need for refrigeration during shipping and storage to prevent degradation in temperatures above 8°C. Heat-stable carbetocin may remain active long-term in hot and humid climates, and could potentially reduce the incidence of PPH in areas where cold storage is difficult to achieve and maintain,and where 99% of maternal deaths due to PPH currently occur.

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 (Carbetocin Haemorrhage Prevention) rail, the world’s largest clinical trial in postpartum haemorrhage, is being undertaken to compare the effectiveness and safety of heat-stable carbetocin to oxytocin in the prevention of postpartum haemorrhage after vaginal births. The trial conducted by the Human Reproduction Program (HRP) at the World Health Organization enrolled nearly 30,000 women in 10 countries including Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the UK. Heat-stable carbetocin was researched and developed by Ferring Pharmaceuticals and the CHAMPION trial was funded by MSD for Mothers.
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