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TRAAP2 study results look promising, but more data are needed
The prophylactic use of tranexamic acid (TXA) may prevent hemorrhage following cesarean delivery, according to a recent study presented at the Society for Maternal-Fetal Medicine’s (SMFM) 41st Annual Pregnancy Meeting.
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“TXA has been studied extensively for its effectiveness in reducing the risk of bleeding in other surgical fields, such as trauma, orthopaedic and cardiac surgery,” says Justin Lappen, MD, a maternal-fetal medicine specialist in Cleveland Clinic’s Department of Obstetrics and Gynecology, who did not participate in the study. “We began using it a few years ago in obstetrics following the publication of the WOMAN trial in 2017. The thought was then that TXA could be used for prophylaxis; however, the TRAAP trial did not show a benefit and therefore was not used to prevent bleeding from vaginal delivery.”
The WOMAN trial found a decrease in hemorrhage-related deaths in women given TXA after the onset of hemorrhage compared with a placebo, according to Dr. Lappen. In the Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery trial (TRAAP), women received tranexamic acid at the time of vaginal birth as a potentially preventive measure. The TRAAP study found no statistically significant reduction in the risk of postpartum hemorrhage with prophylactic TXA, Dr. Lappen explains.
“We know the risk of bleeding is greater with cesarean delivery compared with vaginal delivery. So, in the TRAAP2 trial, the team sought to determine if 1g of TXA would prevent blood loss of > 1,000 or the need for transfusion by postpartum day two,” says Dr. Lappen.
A total of 4,153 women were assessed for this primary outcome. There was about a 5% difference between the TXA and placebo groups, which was statistically significant. Specifically, blood loss of > 1,000 ml or transfusion occurred in 556 of the 2,086 women (26.7%) in the TXA group, compared with 653 of the 2,067 women (31.6%) in the placebo group.
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Dr. Lappen believes these results are interesting, and looks forward to the results of a similar trial currently being conducted by the Maternal-Fetal Medicine Units Network (NCT03364491). Meta-analysis may also be helpful here, as outcomes such as transfusion or hysterectomy may be uncommon enough that we might not see enough of them in any one study. “It’s possible that if we had more data, we may see more beneficial effects of TXA – not only in preventing strictly defined postpartum hemorrhage, but in preventing interventions required to treat hemorrhage or downstream adverse effects of hemorrhage, which can be quite meaningful to patients.”
“A transfusion or other procedures for post-partum hemorrhage can significantly affect a woman’s health, recovery and experience of childbirth,” Dr. Lappen explains. “Spending those first 24 hours with your baby – beginning to bond and breastfeed – these things can be meaningfully interrupted by a major hemorrhage. TXA is a safe and inexpensive medication that could reduce the risk of complications from post-partum hemorrhage.”
Currently, patients at Cleveland Clinic receive TXA if they experience postpartum hemorrhage or excessive bleeding from surgery. “The TRAAP2 study is really the first major trial to looks at the use prophylactic of TXA. When we get the results of the US trial, hopefully later this year, we’ll be able to interpret the results of both studies together and make a meaningful decision about adopting the practice,” Dr. Lappen concludes.
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While TXA is generally considered safe, it might not be appropriate for women with abnormal kidney function or seizure disorders.
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