Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery

The New England Journal of Medicine:

Postpartum hemorrhage is a major cause of maternal death and severe maternal complications after childbirth. Currently, the prophylactic administration of a uterotonic agent immediately after delivery is recommended for all women as the only procedure that has been proved to reduce rates of postpartum hemorrhage.

Tranexamic acid, an antifibrinolytic agent, reduces the incidence of bleeding in elective surgery and mortality among patients with trauma, without increasing the incidence of vascular occlusive events, and is consequently recommended in these situations.

Tranexamic acid was recently shown to reduce bleeding-related mortality among women with postpartum hemorrhage, especially when the drug was administered shortly after delivery.

A meta-analysis of data from individual patients, including data from patients with trauma and women with postpartum hemorrhage, suggested the importance of early treatment.

Every 15-minute delay in administration was associated with a reduction of approximately 10% in the benefit against bleeding-related deaths, and no significant benefit was noted when the drug was administered more than 3 hours after delivery.

These findings suggest that tranexamic acid be considered as an intervention not only to treat but to prevent postpartum coagulopathy, but evidence to support a prophylactic effect on postpartum hemorrhage is weak.

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This trial investigates whether the administration of tranexamic acid in addition to a prophylactic uterotonic agent (oxytocin) would decrease the incidence of postpartum hemorrhage after vaginal delivery, as compared with an uterotonic agent alone.

Of the 4079 women who underwent randomization, 3891 had vaginal delivery. The rate of postpartum hemorrhage (the primary outcome) was lower in women who received tranexamic acid compared with those who received placebo.

Women who received prophylactic tranexamic acid in addition to oxytocin after vaginal delivery had a lower rate of postpartum hemorrhage.

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Abstract

Background

The use of tranexamic acid reduces mortality due to postpartum hemorrhage. Authors investigated whether the prophylactic administration of tranexamic acid in addition to prophylactic oxytocin in women with vaginal delivery would decrease the incidence of postpartum hemorrhage.

Methods

In a multicenter, double-blind, randomized, controlled trial, authors randomly assigned women in labor who had a planned vaginal delivery of a singleton live fetus at 35 or more weeks of gestation to receive 1 g of tranexamic acid or placebo, administered intravenously, in addition to prophylactic oxytocin after delivery. The primary outcome was postpartum hemorrhage, defined as blood loss of at least 500 ml, measured with a collector bag.

Results

Of the 4079 women who underwent randomization, 3891 had a vaginal delivery. The primary outcome occurred in 156 of 1921 women (8.1%) in the tranexamic acid group and in 188 of 1918 (9.8%) in the placebo group. Women in the tranexamic acid group had a lower rate of provider-assessed clinically significant postpartum hemorrhage than those in the placebo group and also received additional uterotonic agents less. Other secondary outcomes did not differ significantly between the two groups. The incidence of thromboembolic events in the 3 months after delivery did not differ significantly between the tranexamic acid group and the placebo group.

Conclusions

Among women with vaginal delivery who received prophylactic oxytocin, the use of tranexamic acid did not result in a rate of postpartum hemorrhage of at least 500 ml that was significantly lower than the rate with placebo.