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Preventive Approach to C-Section Bleeding Pans Out in Trial

— Treatment lowered risk of early blood loss and transfusion, but not more severe hemorrhage

MedpageToday

Women who received tranexamic acid after C-section in a large randomized trial showed reductions in postpartum bleeding by some measures, researchers said.

Compared with a placebo group, mothers in the tranexamic acid group had 16% lower risk of postpartum blood loss above 1,000 mL, as well as fewer transfusions by day 2 after birth (adjusted risk ratio 0.84, 95% CI 0.75-0.94), according to Loïc Sentilhes, MD, PhD, of the Bordeaux University Hospital in France, and colleagues.

Mean calculated blood loss was also lower among those who took tranexamic acid (680±748 vs 787±750 mL), and the same was true for mean peripartum changes in hemoglobin and hematocrit, Sentilhes reported at the Society for Maternal-Fetal Medicine annual meeting.

Sentilhes noted, however, that tranexamic acid did not reduce other markers of postpartum blood loss, including mean gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, and postpartum transfusion.

"Among women with cesarean receiving prophylactic uterotonics, tranexamic acid significantly decreased the rate of calculated estimated postpartum blood loss above 1,000 mL or transfusion by day 2," Sentilhes said in the presentation.

Loralei Thornburg, MD, a maternal-fetal medicine specialist at the University of Rochester Medical Center in New York, who was not involved in this trial, said these findings provide significant data for the use of tranexamic acid as a prophylactic, specifically in patients at a high risk of hemorrhage.

"This gives us another tool to say, 'if a patient is at risk (i.e., delivering via cesarean), does using prophylactic tranexamic acid have some benefit?'" Thornburg said. "The answer is yes, in early blood loss and early transfusion, but maybe no in more severe hemorrhage."

Tranexamic acid, an antifibrinolytic agent used to prevent or treat serious bleeding, has been previously demonstrated to . Prior studies have reported that prophylactic administration of tranexamic acid with uterotonics can reduce bleeding, but Sentilhes stated that many of those studies were small, single-center trials and had methodological flaws.

In his presentation, Sentilhes shared findings from , a multicenter, double-blind, randomized controlled trial, to investigate whether administering tranexamic acid and prophylactic uterotonics decreases the incidence of postpartum hemorrhage after C-section.

Investigators recruited participants from 27 hospitals in France. Participants were randomized to receive either 1 g of tranexamic acid or a placebo. Medication was administered in the first 3 minutes after birth, after one routine prophylactic injection of uterotonics (5 or 10 IU of oxytocin or 100 mg of carbetocin) and cord clamping.

The group included women who were 18 or older, had a singleton or twin pregnancy, were at ≥34 weeks' gestation, and were expected to undergo a C-section. Patients were excluded if they were at an increased risk of venous or arterial thrombosis, had epilepsy or seizures, or had a prenatal hemoglobin level less than 90 g/L in the week before delivery.

The final analysis included 4,153 women who were assessed for postpartum hemorrhage, with 2,086 receiving the intervention. In both the tranexamic acid and control groups, about 58% of participants received prophylactic oxytocin and 40% received carbetocin.

Approximately 27% of participants in the tranexamic acid group experienced blood loss above 1,000 mL or had a transfusion by day 2, compared with 32% in the control group.

Women who took tranexamic acid were more likely to experience nausea or vomiting (43% vs 36% in the placebo group). Additionally, at 3 months postpartum, thrombotic events occurred in 0.4% of the intervention group and 0.1% of the placebo group, but this finding was not significant.

  • Amanda D'Ambrosio is a reporter on app’s enterprise & investigative team. She covers obstetrics-gynecology and other clinical news, and writes features about the U.S. healthcare system.

Disclosures

Sentilhes did not report any conflicts of interest.

Primary Source

Society for Maternal-Fetal Medicine

Sentilhes L, et al "Tranexamic acid for the prevention of postpartum hemorrhage after cesarean delivery: the TRAAP2 trial" SMFM 2021; Abstract 1.