An estimated 100,000 women die from severe bleeding after giving birth each year, making postpartum hemorrhage the number one cause of death around the world, and a particularly important cause of maternal death in Africa and Asia.
New research shows that a decades-old drug, tranexamic acid, may decrease the risk of death from postpartum bleeding by about a third. It works by helping to keep naturally forming blood clots intact.
Researchers in an international clinical trial tested whether the blood clot stabilizer could become an essential tool for fighting excessive bleeding soon after giving birth.
The World Maternal Antifibrinolytic Trial, or WOMAN trial, was coordinated by researchers at the London School of Hygiene & Tropical Medicine Clinical Trials Unit to study the effects of tranexamic acid on death, hysterectomy and other maternal outcomes in women with postpartum hemorrhage.
The trial—a global collaboration of obstetricians, midwives, pharmacists, administrators, ethics committees and regulatory agencies—started recruitment in March 2010 and completed in April 2016, recruiting a total of 20,060 women from 193 hospital in 21 countries.
Women older than 16 years who had a clinical diagnosis of postpartum hemorrhage after a vaginal birth or cesarean section were randomly assigned to receive either 1 g of intravenous tranexamic acid or a placebo, in addition to usual care.
The results showed 1.2 percent of women died in the tranexamic acid group vs 1.7 percent in the placebo group.
If used within three hours of clinically diagnosed hemorrhage, tranexamic acid reduced death due to bleeding by about a third. In addition, the trial findings also showed that the drug reduced the need for urgent surgery to control bleeding by more than 35 percent. Although tranexamic acid did not prevent hysterectomy, it substantially reduced the number of laparotomies to control bleeding. Researchers noted that, while hysterectomy might be a last resort to control bleeding in high-income settings, in Africa and Asia where many women are anemic and blood supplies are limited, hysterectomy is often an early intervention to prevent death from blood loss.
The trial found no increase in complications from the drug for either mothers or babies.
Tranexamic acid is an inexpensive drug and has been around since the 1950s, making it widely available. So, why isn’t it used more often?
The drug was created by Japanese doctor Utako Okamoto in the 1960s to help mothers who hemorrhage after childbirth. “It was Okamoto’s dream to save women,” said Haleema Shakur, a principal investigator in the WOMAN Trial in a recent article in NPR. “But she couldn’t convince doctor’s to test the drug on postpartum hemorrhaging.”
Another disadvantage is its delivery. For the study, tranexamic acid was delivered via intravenous injection. However, in low-income and middle-income countries, many deaths from postpartum bleeding occur at home or in settings where injections may not be feasible.
Therefore, the researchers urge studies of tranexamic acid given by other routes.
The study was published April 27, 2017 in The Lancet.
Filed Under: Drug Discovery
