Generate evidence on the safety and efficacy of heat-stable carbetocin for postpartum haemorrhage treatment, to overcome barriers to quality care

Challenges

Oxytocin, the most used medicine for preventing and treating postpartum haemorrhage, requires cold chain storage to remain effective. Because this is difficult to maintain in many resource-limited settings, the quality of the medicine can suffer.

Heat-stable carbetocin (HSC) is an alternative product with adequate high-quality supply and no cold chain requirements. It has been recommended by the WHO for postpartum haemorrhage prevention, but evidence to understand its potential benefits as a treatment is lacking. This limits its clinical utility and raises safety concerns about its off-label use for treatment.

Solutions

Unitaid funded research will generate and disseminate safety and efficacy evidence on the use of HSC for treating postpartum haemorrhage. A WHO recommendation for HSC as treatment would enable a high-quality, shelf-stable treatment option for PPH, as well as unlock the HSC prevention market to further expand access to this new drug.

This research will be led by the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), the main instrument within the United Nations system for research in human reproduction.

‘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. This important funding announcement from Unitaid along with our collaboration will potentially lift those barriers and go some way to reducing the 70,000 preventable deaths we see from postpartum haemorrhage every year.’

Dr Soumya Swaminathan, Chief Scientist, World Health Organization.

The impact we are seeking

Collectively with the other initiatives in Unitaid’s postpartum haemorrhage portfolio, this project will serve to reduce deaths caused by postpartum hemorrhage, which disproportionately affect women in low- and middle-income countries (LMICs), especially those who lack access to quality care due to poverty, geography, or cultural barriers. Nearly all maternal deaths from bleeding after childbirth occur in LMICs, mostly in sub-Saharan Africa and South Asia (80% of all deaths).

At scale, these products could reduce deaths from postpartum haemorrhage by more than 10% within 5 years from the projects’ end. This supports the Sustainable Development Goal to reduce the global maternal mortality rate to fewer than 70 per 100,000 live births. This investment will also strengthen equity and bridge the gap in terms of access to quality and life-saving interventions for women who give birth in low-resource settings.