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Stable-Heat Carbetocin:A drug that could save many lives

By Vivian Agaba

Added 13th July 2018 05:57 PM

Excessive bleeding commonly known as postpartum hemorrhage (PPH) after vaginal birth is the number one cause of these deaths.

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Excessive bleeding commonly known as postpartum hemorrhage (PPH) after vaginal birth is the number one cause of these deaths.

PIC: Stable-Heat Carbetocin is the new drug that could save thousands of women from labour. According to resaerch, the drug helps to control excess bleeding among mothers.

HEALTH


KAMPALA - In low and middle income countries; where Uganda falls, thousands of women die annually due to maternal and child birth related complications.


Excessive bleeding, commonly known as postpartum hemorrhage (PPH) after vaginal birth is the number one cause of these deaths.

In the recent clinical trial, the largest of its kind studied close to 30,000 women who had viginal births, commonly refered to as normal births in 10 countries, new data shows that heat-stable carbetocin is as effective as oxytocin.

Oxytocin is the current standard of care in preventing excessive bleeding following vaginal birth recommended by the World Health Organisation (WHO).

The findings of this new drug were published in the New England Journal of Medicine recently.

Ten countries that took part in the study include; Argentina, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, the United Kingdom and Uganda where over 3,185 women were recruited in Uganda.

Each woman was randomly given a single injection of either heat-stable carbetocin or oxytocin immediately following the birth of her baby.

The study found that both drugs were equally effective at preventing excessive bleeding after birth.

Prof. Josaphat K. Byamugisha, the co-principal investigator of the study in Uganda explains that the new drug fits well in the country’s humid and hot temperatures unlike oxytocin which has limitations when it comes to storage and transportation. 

According to the study results, oxytocin must be stored and transported at 2-8 degrees Celsius, but studies from low and middle income countries where these deaths occur revealed degradation and loss of efficacy in oxytocin ampoules, which could be due to inadequate storage and distribution conditions and therefore many women might get it only to find it has lost its efficacy due to heat exposure.

On the other hand, heat-stable carbetocin maintains effectiveness for at least three years at 30 degrees Celsius and six months at 40 degrees Celsius.  

“Though in action the two drugs are the same, stable-heat carbetocin does not require refrigeration, it remains stable and effective for a longer period.

"This drug will be suitable for our environment with higher and humid temperatures and can still maintain the ability to work,” Byamugisha says.

“In most of our health facilities, oxytocin was stored on the surface due to lack of fridges, and this would reduce on its effectiveness.

"We are optimistic about the new drug and looking forward to have it in the country,” he added.

Statistics

Globally, every year, 14 million women are affected by PPH, which is the leading direct cause of maternal deaths worldwide, causing approximately 70,000 deaths per year.

Uganda has made some remarkable decline in maternal mortality rates from 438 deaths per 100,000 live births registered in the 2011 Uganda Demographic Healthy Survey report to the current 336 deaths per 100,000 live births in 2016, however, these deaths must be reduced further.

“This is an important step forwards in PPH prevention and these results pave the way for heat-stable carbetocin to potentially save the lives of thousands of women, especially in areas where cold-chain transport and storage is not feasible,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals.

Adding: “We will now work with the WHO and MSD for Mothers to make heat-stable carbetocin available in countries where it is needed most, protecting women and families around the world.

Dr. Olive Sentumbwe-Mugisa, the family health and population advisor, WHO says stakeholders engagements will have to first take place to decide how best to implement the use of the drug before it is brought on the Ugandan market.

About the study

This WHO study, also referred to as the CHAMPION (Carbetocin Haemorrhage Preventoin) trial, was funded by MSD for Mothers.

Heat-stable carbetocin was provided by Ferring Pharmaceuticals, the product innovator and oxytocin was provided by Novartis for the study.

The study was conducted under a collaborative arrangement between WHO, MSD for Mothers and Ferring Pharmaceuticals.

Following the positive results from the trial, the parties will now work to advance affordable access to this lifesaving drug in countries that have a high burden of maternal deaths.

 

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