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Tranexamic Acid for the Prevention of Blood Loss after Cesarean Among Women With Twins. A Secondary Analysis of the TRAAP2 Randomized Clinical Trial

L. Sentilhes, H. Madar, M. Le Lous, M. Senat, N. Winer, P. Rozenberg, G. Kayem, E. Verspyck et al.

American Journal of Obstetrics and Gynecology, 2022

4,551 participants · 11 citations

Abstract

BACKGROUND

Although prophylactic tranexamic acid administration at cesarean delivery resulted in a lower incidence of calculated estimated blood loss > 1000 mL or red-cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAAP2 trial) makes its use questionable. The magnitude of its effect may differ in women at higher risk of blood loss, including those with multiple pregnancies.

OBJECTIVE

To compare the effect of tranexamic acid vs placebo to prevent blood loss at cesarean delivery among women with multiple pregnancies.

STUDY DESIGN

Secondary analysis of the TRAAP2 trial data including 319 women with multiple pregnancies in this double-blind, randomized controlled trial from March 2018 through January 2020 in 27 French maternity hospitals. Women with a cesarean before or during labor at 34 or more gestational weeks were randomized to receive intravenously 1 g of tranexamic acid (n=160) or placebo (n=159), both with prophylactic uterotonics. The primary outcome was a calculated estimated blood loss > 1000 mL or a red blood cell transfusion by 2 days after delivery. Secondary outcomes included clinical and laboratory blood loss measurements.

RESULTS

Of the 4551 women randomized in this trial, 319 had a multiple pregnancy and cesarean delivery, 298 (93.4%) with primary outcome data available. This outcome occurred in 62 of 147 women (42.2%) in the tranexamic acid group and 67 of 152 (44.1%) receiving placebo…

How strong is the evidence?

Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 4,551 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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