Study Suggests Life-Saving Hemorrhage Drug Could Be Widely Accessible

Recent research indicates that tranexamic acid (TXA), a medication used for severe post-childbirth hemorrhage, can be safely and effectively delivered via intramuscular injection, and also tolerated in oral form, although the latter takes longer to reach effective blood levels. This study proposes that the provision of TXA through various routes such as intramuscular and oral administration could make this life-saving drug accessible to women worldwide, particularly in low and middle-income countries where healthcare facilities may be sparse or childbirth often takes place at home.

The research involved scholars from the London School of Hygiene & Tropical Medicine (LSHTM), who found that TXA, a drug designed to combat severe postpartum hemorrhage, can be administered safely via intramuscular injection, achieving therapeutic levels swiftly.

The Woman-PharmacoTXA Phase 2 trial provided the data, emphasizing the potential for intramuscular injection as an alternative to more common intravenous methods. Intravenous delivery often proves challenging in situations like home births or remote healthcare contexts.

Oral TXA was also found to be well-tolerated, but on average, it took approximately an hour to reach therapeutic blood levels, rendering it less suitable for emergency situations.

These findings were published in the British Journal of Obstetrics and Gynaecology.

Postpartum hemorrhage (PPH) is one of the major causes of maternal death globally, accounting for most of the 70,000 annual deaths in low and middle-income countries.

The earlier WOMAN trial provided critical evidence for the life-saving potential of TXA in treating PPH. Originally used in surgery and later in trauma, TXA functions by stopping the breakdown of blood clots.

In many low and middle-income countries, births often occur at home, limiting access to healthcare facilities and making intravenous TXA administration difficult. Consequently, alternative routes of administration have been explored.

This trial involved an international team, including members from LSHTM, that recruited over 120 women aged 18 and older who were scheduled to undergo a cesarean section at two Pakistani hospitals and one in Zambia between December 2020 and June 2021. All these women had one or more risk factors for postpartum hemorrhage.

This study is the first trial to test different routes of administration in women during childbirth and the first to specifically test the intramuscular route in pregnant women.

Both intramuscular and oral TXA were well-tolerated, with no serious side effects for mothers or newborns. Both routes achieved target TXA concentrations in maternal blood, though it took an hour for oral TXA. However, intramuscular TXA reached therapeutic concentrations within ten minutes, which was sustained for over four hours.

The authors are confident that these results warrant further comparative Phase 3 clinical trials (I’M WOMAN) starting in August of this year. These trials aim to determine if intramuscular administration can be as effective as intravenous methods in reducing postpartum bleeding.

Professor Haleema Shakur-Still, a co-author and Professor of Global Health Clinical Trials at LSHTM, emphasized the significant implications of successful intramuscular TXA administration, especially in low and middle-income countries where women often give birth at home.

Co-author Professors Rizwana Chaudhri and Dr. Mwansa Ketty Lubeya, based in Pakistan and Zambia respectively, highlighted the practical benefits of intramuscular TXA in their countries.

Dr. Ian Roberts, co-author and Professor of Epidemiology at LSHTM, expressed optimism for the intramuscular route’s efficacy and anticipated a large global trial starting in August, hoping to influence WHO guidelines and make this life-saving treatment universally accessible.

Reference: “Alternative routes for tranexamic acid treatment in obstetric bleeding (WOMAN-PharmacoTXA trial): a randomised trial and pharmacological study in caesarean section births” by Haleema Shakur-Still, Ian Roberts, et al., 5 April 2023, British Journal of Obstetrics and Gynaecology. DOI: 10.1111/1471-0528.17455

The Bill and Melinda Gates Foundation and the Wellcome Trust funded the study.

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• The London School of Hygiene & Tropical Medicine (LSHTM)
• British Journal of Obstetrics and Gynaecology
• Bill and Melinda Gates Foundation
• Wellcome Trust