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Thursday, April 13, 2023

Tranexamic acid appears to be no more effective than placebo in reducing the need for blood transfusions or preventing maternal death in patients with an increased risk of bleeding due to caesarean section, according to a study funded by the National Institutes of Health. Tranexamic acid slows the natural breakdown of blood clots and is considered promising for reducing the risk of excessive postpartum bleeding — known as postpartum hemorrhage — after a cesarean section.

In addition, patients who received tranexamic acid had a slightly lower need for additional medical or surgical interventions to treat postpartum hemorrhage and a slightly lower red blood cell count.

The study was led by Luis D. Shown in New England Journal of Medicine. Funding was provided by the National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

“Our findings differ from those of previous trials, which were smaller and therefore did not have the statistical power to detect difference in the need for transfusions between groups,” said study author Monica Longo of NICHD’s Pregnancy and Perinatal Branch. . “The current study included participants from 31 birthing centers across the United States and found no benefit from the drug, compared to placebo.”

Previously, researchers hypothesized that since tranexamic acid prevents the breakdown of blood clots, the drug might slow blood loss and reduce the risk of postpartum hemorrhage. Tranexamic acid has been found to be effective among women with postpartum hemorrhage. The researchers sought to determine the drug’s effectiveness for patients undergoing caesarean sections who had no bleeding at the time of treatment.

The researchers assigned 11,000 patients to receive either intravenous tranexamic acid or a placebo after clamping the umbilical cord at the time of cesarean section. The study included women who underwent both scheduled and unscheduled caesarean sections.

The researchers reported the results as one primary outcome of events that could be expected with postpartum hemorrhage, need for red blood cell transfusions or death. These events occurred in 201 patients (3.6%) in the tranexamic acid group and 233 (4.3%) in the placebo group, a difference that was not statistically significant. For the placebo group, one death occurred. There were no deaths in the tranexamic acid group. There was no significant difference between the groups for the secondary outcome of blood loss estimated at more than 1 liter during the procedure: 7.3% in the tranexamic acid group, 8% in the placebo group.

However, the study found that patients who received tranexamic acid had a lower need for additional medical or surgical interventions to treat postpartum bleeding, compared to the placebo group (16.1% vs. 18%), and a lower decrease in red blood cell counts after a cesarean section. (1.8 grams per deciliter vs. 1.9 grams per deciliter).

The tranexamic acid group had a higher risk of postpartum infection, 3.2% to 2.5%. The authors note that previous trials have not observed a difference in infection rates between groups, and add that the finding needs to be confirmed by additional research.

about the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, improve the lives of children and adolescents, and improve capabilities for all. For more information, visit https://www.nichd.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, includes 27 institutes and centers and is part of the US Department of Health and Human Services. The National Institutes of Health is the primary federal agency that conducts and supports basic, clinical, and multidisciplinary medical research, investigating the causes, treatments, and cures for both common and rare diseases. For more information about the National Institutes of Health and its programs, visit www.nih.gov.

The National Institutes of Health… Turning Discovery into Health®


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