NEW YORK (Reuters Health) – Pregnant women given tranexamic acid immediately after their cesarean section are 16% less likely to experience postpartum hemorrhage, according to results of the TRAAP2 clinical trial.

The test, on 4,431 women, found that 26.7% of the women given the drug had an estimated blood loss of more than 1,000 ml or required a transfusion within two days of the surgery. In the placebo group, the rate was 31.6% (P=0.003).

“The most important message is that tranexamic acid works when given in addition to uterotonics,” chief author Dr. Loic Sentilhes of Bordeaux University Hospital, in France, told Reuters Health in a telephone interview.

“The effect is not huge” so it may not change practice, he said. “But the risk of adverse events is very low.”

Another reason for caution is that when the research team looked at individual secondary outcomes, such as postpartum blood transfusion, gravimetrically estimated blood loss, clinically significant postpartum blood loss as assessed by the doctor, or emergency surgery, the rates were not significantly better in the tranexamic acid group.

More data are needed, he said, and at this point routine use of the treatment would be “questionable. No effect is sufficiently high to recommend it for all women to have.”

Smaller trials had suggested tranexamic acid reduced postpartum blood loss after a cesarean. Other research has shown it can lower the odds of transfusion in elective surgery and the risk of bleeding-related mortality in a woman experiencing a postpartum hemorrhage.

TRAAP2, the results of which appear in the New England Journal of Medicine, was done at 27 maternity hospitals in France.

The study included women who were at week 34 in their pregnancy or later. All received intravenous administration of a prophylactic uterotonic agent along with either 1 g of tranexamic acid or placebo, usually within the three minutes after birth (however in a quarter of the patients it was done later, a violation of protocol).

When the researchers looked at specific groups of patients, they found a 21% reduction in the primary outcome among women who delivered before labor and a 20% reduction among women not considered at risk for postpartum hemorrhage. Both were statistically significant.

The researchers also saw a 12% reduction in the primary endpoint among women who were at risk for postpartum hemorrhage and a 9% reduction among women who delivered during labor, but the confidence intervals were too broad to make those findings statistically significant.

A third of the women had their cesarean performed during labor.

“The only risk of adverse events at that dosage is an increase in the gastrointestinal side effects,” said Dr. Sentilhes.

Nausea and vomiting occurred in 43.0% of tranexamic-acid recipients versus 36.3% in the placebo group (P<0.001).

The rates of thromboembolic events within three months of delivery were not statistically different between the two groups – 0.4% with tranexamic acid versus 0.1% with placebo (P=0.08) – but the trend offered a reason for caution, said Dr. Sentilhes.

Maternal satisfaction scores were similar between the two groups at day 2 and after two months.

However, “more subtle health dimensions, such as quality of life or mother-infant relationship, were not explored,” the researchers said.

SOURCE: https://bit.ly/32HQc4F The New England Journal of Medicine, April 28, 2021.

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