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Large trial finds promising results for new formula to treat postpartum bleeding

The WHO collaborated with pharmaceutical company Merck, Sharpe & Dohmeto compare the effects of carbetocin with oxytocin on postpartum bleeding after a vaginal birth.

Postpartum bleeding continues to be the biggest reason behind maternal deaths all over the world. Around 661,000 deaths were reported worldwide between 2001 and 2009 on account of postpartum bleeding. More than 70% of the postpartum deaths are due to bleeding, and most of them are caused due to poor contraction of the uterus after childbirth.

Oxytocin is hard to store and transport in low and middle-income countries

The World Health Organization (WHO) recommends oxytocin as the drug of choice for the prevention of excessive bleeding after childbirth. However, it must be stored and transported at 2-8°C, which is difficult to do in low and middle-income countries. Because of this, women giving birth in such countries have less access to this life-saving drug and even if they do, oxytocin becomes less effective due to heat exposure.

Carbetocin does not require cold storage and transport

Carbetocin, an oxytocin analog, is heat stable and does not require cold chain storage and transport. It has been shown to be stable over a period of 36 months at 30°Cand 75% relative humidity.

A team of researchers from WHO in collaboration with the pharmaceutical company Merck & Co. recently conducted a study to explore the potential of heat-stable carbetocin in preventing postpartum bleeding and thus maternal deaths. This study was published in The New England Journal of Medicine.

The study included 29,645 women from around 10 countries who had given birth vaginally. Each woman was randomly assigned to a single injection of either carbetocin or oxytocin, immediately after giving birth to her baby. Both the drugs were kept in cold storage (2-8°C) to maintain blinding of the study.

Both drugs were equally effective

The results of the study showed that both the drugs were equally effective in preventing blood loss of at least 500 mL after birth or the use of additional uterotonic agents. The frequency of blood loss in women given carbetocin was 14.5%, as compared to the frequency of blood loss in women given oxytocin which was 14.4%.

Carbetocin was found to be non-inferior to oxytocin preventing blood loss of at least 500 mL. However, non-inferiority was not shown in the prevention of blood loss of at least 1000 mL (1.51% frequency with carbetocin, compared with 1.45% with oxytocin).

The study concluded that heat stable carbetocin is as effective as oxytocin for preventing excessive postpartum bleeding after vaginal birth. This shows that carbetocin could be beneficial in low and middle-income countries, where oxytocin can get degraded due to exposure to higher temperatures.

Written by Pratibha Duggal

References:

  1. Widmer M, Piaggio G, Nguyen TMH, Osoti A, Owa OO, Misra S, Coomarasamy A, Abdel-Aleem H, Mallapur AA, Qureshi Z, Lumbiganon P, Patel AB, Carroli G, Fawole B, Goudar SS, Pujar YV, Neilson J, Hofmeyr GJ, Su LL, Ferreira de Carvalho J, Pandey U, Mugerwa K, Shiragur SS, Byamugisha J, Giordano D, GĂĽlmezoglu AM; WHO CHAMPION Trial Group.Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med. 2018.
  2. Torjesen I. Alternative drug to prevent postpartum bleeding could save many lives in low-income countries. BMJ. 2018;361:k2859.
Pratibha Duggal
Pratibha Duggal
Pratibha Duggal has a post-graduate degree in pharmaceutical chemistry. She is currently pursuing a post-graduate diploma in clinical research, pharmacovigilance, and regulatory affairs from the Academy of Applied Pharmaceutical Sciences in Toronto, Canada. She started her career as a pharmacovigilance scientist and is an expert on drug safety. She recently switched careers to become a medical writer and now has more than three years of experience in this field. She enjoys being a part of the Medical News Bulletin team and contributing to educating readers about the latest research in the medical field.
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