An inexpensive intervention reduces maternal mortality due to Post-partum hemorrhage.

An inexpensive intervention like Tranexamic acid (TXA) has the potential to significantly reduce maternal death due to Post-Partum hemorrhage(PPH) when used in timely manner, report the results of large randomized control trial.

The WOMAN (World Maternal Antifibrinolytic) Trial results along with an accompanying editorial were published online April 26, 2017 in Lancet.

Primary Post-partum hemorrhage is responsible for about 100 000 deaths every year primarily in developing countries and in low resource settings.

Before the WOMAN trial, tranexamic acid was shown to be effective in surgical blood loss and trauma cases but a review of literature failed to document any research in use of tranexamic acid in postpartum hemorrhage. Interestingly, the drug was originally developed for controlling hemorrhage in obstetrics and gynecology.

Further, WHO guideline in 2012 recommended “tranexamic acid should be used for the treatment of post-partum hemorrhage when uterotonics fail to control the bleeding or when the bleeding is thought to be due to trauma,” but the results were extrapolated from surgery or trauma cases.

Comprising of 20,060 patients with a clinical diagnosis of PPH during normal or cesarean delivery, the WOMAN trial spanned across 193 hospitals in 21 countries.

All patients received normal obstetric care and were randomized to receive 1 g tranexamic acid or placebo by slow intravenous injection. If bleeding persisted after 30 minutes or restarted after once controlled within 24 hours, a dose of TXA was repeated.  

Trial results were evaluated in terms of number of deaths from all causes or hysterectomy within 42 days of drug administration. Deaths due to bleeding was also looked at as main secondary outcome.

The results showed that treatment with TXA reduces the chances of death due to bleeding by almost 20% as compared to placebo (risk ratio [RR], 0.81; P = .045). The effect was maximum when TXA was used within 3 hours of delivery (RR, 0.69; P = .008).

When the drug was used after 3 hours, there was no significant reduction in risk of death due to bleeding (RR, 1.07; P = .70).

The risk of death due to hysterectomy and all causes or hysterectomy including pulmonary embolism, organ failure, sepsis, and eclampsia were similar between the study and control group.

TXA did not increase the risk of thromboembolic events as compared to placebo.

An accompanying editorial writes that “Hemorrhage accounts for 18% of these deaths, and is a particularly important cause of maternal mortality in Africa and Asia. Discovering new ways to prevent maternal death, especially from bleeding, therefore continues to be a high priority, and WOMAN trial is an important milestone in that quest.”

The authors recognize that most deaths due to PPH occur in developing or low resource setting countries, where administering IV TXA may not be feasible.  So, studies investigating alternate routes of TXA administration should be planned.

The trial also supported the WHO recommendation of inclusion of tranexamic acid in treatment guidelines for primary postpartum hemorrhage but with a caveat that it should be given as soon as possible.

Full text of the article can be accessed here.

Full text of the editorial can be accessed here.

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