New drug to assist with traumatic childbirth could be made accessible for all 

Intramuscular administration of tranexamic acid (TXA), a drug used to target severe bleeding after childbirth, is safe and quickly reaches therapeutic concentrations in pregnant women, according to a new study.

The findings, from the Woman-PharmacoTXA Phase two trial, highlight that intramuscular injection may be a potential alternative to current intravenous approaches, which are often unsuitable in home births or rural care settings.

Oral TXA was also well tolerated, but on average took around an hour to reach therapeutic blood concentrations, meaning it could be unsuitable for emergency treatment. Intramuscular TXA reached therapeutic concentrations within ten minutes of injection, which was maintained for over four hours.

The results have been published in the British Journal of Obstetrics and Gynaecology.

Severe bleeding after childbirth, or postpartum haemorrhage (PPH), is one of the leading causes of maternal death worldwide, with most of the 70,000 yearly deaths occurring in low-and middle-income countries.

Results from the earlier WOMAN trial, led by researchers from involving researchers from the London School of Hygiene & Tropical Medicine (LSHTM) with collaboration from 21 countries, provided evidence for the life-saving potential of repurposing TXA for treating PPH.

Originally used in surgery and later in trauma, TXA works by inhibiting the breakdown of blood clots.

Although intravenous administration of TXA is the first option for treatment, many births in LMICs take place at home, with access to healthcare settings often limited. Subsequently, focus has shifted towards finding alternative administration routes.

In this trial, an international research team, including from LSHTM, recruited over 120 women aged 18 or older who were due to give birth by caesarean section at two hospitals in Pakistan and one in Zambia between December 2020 and June 2021. All women had one or more risk factors for postpartum haemorrhage.

The authors conclude that these findings provide enough evidence to conduct comparative Phase 3 clinical trials beginning in August this year. These will aim to determine if intramuscular administration is as effective as intravenous routes in reducing postpartum bleeding.

Professor Haleema Shakur-Still, Co-Author and Professor of Global Health Clinical Trials at LSHTM, said: ‘In many LMICs, women do not give births in healthcare facilities, so if TXA can be given just as successfully intramuscularly as via intravenous injection, this could be of huge significance to the thousands of women who die every year from PPH.’

Image: Brian Tromp