Inexpensive Generic Prevents Bleeding Deaths after Childbirth

An inexpensive generic drug has been found to prevent hemorrhaging in women after childbirth.

The WOMAN Trial, involving more than 20,000 women in 21 countries, found that tranexamic acid “could save the lives of mothers who would otherwise bleed to death after childbirth,” according to the trial’s website. Tranexamic acid is an antifibrinolytic agent. It is on the WHO’s List of Essential Medicines.

In the United States, tranexamic acid is sold under the brand name Lysteda and Cyklokapron, with an indication for treating severe menstrual bleeding. The generic form of the drug costs about $2 per dose.

The study, conducted by the London School of Hygiene and Tropical Medicine, was published in the April 26 issue of The Lancet.

In the trial, death due to bleeding was reduced by about a third when tranexamic acid treatment was given within three hours. Tranexamic acid reduced the need for laparotomy to control bleeding by more than a third.

There were no side effects observed from the drug for either mothers or babies.

“We now have important evidence that the early use of tranexamic acid can save women’s lives and ensure more children grow up with a mother,” the website stated.

Postpartum hemorrhage is the leading cause of maternal death worldwide.

In the randomized, double-blind, placebo-controlled trial, researchers recruited women 16 years and older with a clinical diagnosis of postpartum hemorrhage after a vaginal birth or cesarean section from 193 hospitals in 21 countries.

They randomly assigned women to receive either 1 gram (10 mg/ mL) of IV tranexamic acid or matching placebo, in addition to usual care. If bleeding continued after 30 minutes, or stopped and restarted within 24 hours of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given.

The researchers found that death due to bleeding was significantly reduced in women given tranexamic acid (155 of 10,036 patients versus 191 of 9,985 patients in the placebo group). In women given treatment within three hours of giving birth, death was reduced most significantly (89 in the tranexamic acid group versus 127 in the placebo group).

“Tranexamic acid reduces death due to bleeding in women with post-partum hemorrhage with no adverse effects,” the researchers wrote in The Lancet. “When used as a treatment for postpartum hemorrhage, tranexamic acid should be given as soon as possible after bleeding onset.”