A widely available generic drug first discovered more than 50 years ago called tranexamic acid (TXA) reduces maternal death from bleeding by 31% if given within three hours, a global clinical trial has found. The findings also show that it lowered the need for surgery to control bleeding by more than a third (36%).
TXA works by preventing blood clots from breaking down. More specifically, it reduces bleeding by inhibiting the enzymatic breakdown of fibrinogen and fibrin by plasmin.
Post-partum haemorrhage, which refers to severe bleeding after childbirth (also known as PPH), is the leading cause of maternal death worldwide. More than 100,000 women globally die each year from the condition. This clot-stabilising drug has the potential to reduce that number substantially.
The World Maternal Antifibrinolytic (WOMAN) trial study, led by the London School of Hygiene & Tropical Medicine, involved 20,000 mothers in 193 hospitals in 21 countries.
In the study results, among women given tranexamic acid within three hours, 89 died from bleeding compared with 127 given placebo, in addition to standard care. The researchers found no side effects from the drug for either mothers or babies.
These findings provide the first comprehensive evidence on using tranexamic acid for post-partum haemorrhage and suggest it should be used as a frontline treatment.
Tranexamic acid was invented in the 1960s by a Japanese husband and wife research team, Shosuke and Utako Okamoto. They wanted it to be used to prevent birth hemorrhages, however, they couldn’t persuade local obstetricians at the time to run a clinical trial.
The video below tells the remarkable story of the 98-year old Utako Okamoto, in an interview conducted shortly before her death last year.
Nearly all of the deaths from post-partum haemorrhage occurr in low- and middle-income countries. Although giving birth in a health facility increases the chance of surviving post-partum haemorrhage, many women still die from the condition even within hospitals.
Tim Knott, Senior Partner in Innovations at Wellcome Trust, said:
“Globally, severe bleeding in childbirth remains one of the main causes of maternal death - with alarming numbers of women dying in many low- and middle-income countries. The WOMAN Trial team undertook a hugely important and incredibly ambitious study. Their work stands to make a critical difference in preventing women dying after childbirth."
Current World Health Organization guidelines, based on the previous trauma research, recommend the use of tranexamic acid in post-partum haemorrhage as a subsequent treatment option if uterotonics (drugs to induce contractions) fail to control the bleeding, or if the bleeding is thought to be due to trauma.
Post-partum haemorrhage is defined as a blood loss of more than 500ml within 24 hours of giving birth.
The current study builds on previous research involving trauma patients, which showed that tranexamic acid reduced deaths due to bleeding by almost a third if given within three hours. The research was funded by the Wellcome Trust, Pfizer, Britain’s health department and the Bill and Melinda Gates Foundation.
Shakur, Haleema et al. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial The Lancet DOI: http://dx.doi.org/10.1016/S0140-6736(17)30638-4
Image: Gilberto Santa Rosa/CC BY 2.0