Sh5bn funding to test new drugs that stop postpartum bleeding

A 3D molecular model of carbetocin, one of the oxytocin alternatives. Carbetocin does not require cold chain storage. 

On August 11, Mr Fredrick Oloo lost his beloved wife to excessive bleeding at a rural hospital in Siaya County.

Reason? Unavailability of drugs to stop the bleeding.

In Kenya currently, most hospitals are using oxytocin as the first-line drug for preventing excessive bleeding after childbirth.

However, it must be stored and transported at 2-8 degrees Celsius to remain effective, which is hard to achieve in many counties and rural hospitals. This denies many women access to the life-saving drug.

And when they can obtain it, the quality of the drug is not always assured due to exposure to heat.

This is expected to change with an injection of $45 million (Sh5.4 billion) by Unitaid, an agency hosted by the World Health Organisation (WHO), to fund research in Kenya.

The amount has been invested across three complementary initiatives, and the agency will fund research needed to optimise use and enable broader access to products that, when implemented at scale, could save tens of thousands of women’s lives.

Together with Jhpiego, a non-profit organisation affiliated with the Johns Hopkins University, Unitaid is out to ensure that babies and their mothers leave hospitals safe and alive.

Importantly, Jhpiego will lead a large-scale demonstration project to inform optimal deployment and scale-up of a critical set of new and newly-recommended postpartum haemorrhage drugs in low-middle-income countries.

The project will involve heat-stable carbetocin and tranexamic acid (TXA), as well as misoprostol, a medicine in tablet form that is recommended by WHO for self-administration to prevent haemorrhage when giving birth at home or in the absence of skilled health personnel.

Carbetocin, which is already recommended for preventing excessive bleeding during childbirth, represents a high-quality alternative to oxytocin as it does not require cold chain storage.

The product, which is already recommended for preventing excessive bleeding during childbirth, represents a high-quality alternative to oxytocin as it does not require cold chain storage.

The clinical trial, coordinated by the World Bank Special Programme of Research, Development and Research Training in Human Reproduction (Human Reproduction Programme) and other entities will evaluate the safety and efficacy of using carbetocin for treating postpartum haemorrhage.

“One life lost to postpartum haemorrhage is one life too many. Through Unitaid’s commitment to expand access to lifesaving drugs and our partnership ... we can prevent the deaths of thousands of women who experience severe bleeding after birth,” said Elaine Roman, the project lead at Jhpiego.

“We are honoured to lead this project and use our decades-long experience in managing complications at birth to propel catalytic change across Africa and Asia and significantly reduce maternal deaths,” added Ms Roman.

With its partners, Unitaid will advance a package of care for preventing and treating postpartum haemorrhage that is better suited to needs in low- and lower-middle income countries where nearly 94 percent of all maternal deaths occur.

Defined as severe bleeding after childbirth, postpartum haemorrhage is the leading cause of maternal mortality worldwide, with stark disparities in survival rates between women in high-versus lower-income countries.

More than half of these deaths occur within 24 hours after childbirth.

The bleeding is caused by either a placenta that is not expelled after birth or when the uterus fails to contract after delivery.

Each year, approximately 14 million women experience postpartum haemorrhage, resulting in 70,000 lives lost. In Kenya, it is the leading cause of maternal mortality, accounting for 34 percent of maternal deaths.

“One in five deaths during childbirth are caused by excessive bleeding. Despite being largely avoidable with access to appropriate tools, each year millions of women suffer the trauma of bleeding. The investment will reduce the inexcusable gap in care, ensuring critical medicines are available and adopted to use where they are needed most,” said Dr Philippe Duneton, the executive director of Unitaid.

The London School of Hygiene and Tropical Medicine will lead a second project aimed at improving access to TXA, a treatment recommended by the WHO that is proven to reduce the risk of death from severe bleeding.

Currently, TXA can only be administered intravenously, which makes it inaccessible in facilities that lack the necessary staff capacity and infrastructure.

The trial will evaluate the safety and efficacy of intramuscular administration of TXA compared to intravenous administration. If intramuscular TXA proves to be as effective, this lifesaving treatment could be made much more widely available, particularly at lower levels of the health system where it is needed most.

The three underutilised drugs recommended by WHO hold great potential to improve the control of postpartum haemorrhage, but several barriers limit their wide scale access and use.

“It is a tragedy that so many women die unnecessarily due to the lack of access to available drugs proven to prevent bleeding after childbirth. These deaths shine a light on continued inequities brought by geography and economy,” said Dr Soumya Swaminathan,  the WHO’s chief scientist.