TY - JOUR
T1 - Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery.
AU - Pacheco, Luis D.
AU - Clifton, Rebecca G.
AU - Saade, George R.
AU - Weiner, Steven J.
AU - Parry, Samuel
AU - Thorp, John M.
AU - Longo, Monica
AU - Salazar, Ashley
AU - Dalton, Wendy
AU - Tita, Alan T.N.
AU - Gyamfi-Bannerman, Cynthia
AU - Chauhan, Suneet P.
AU - Metz, Torri D.
AU - Rood, Kara
AU - Rouse, Dwight J.
AU - Bailit, Jennifer L.
AU - Grobman, William A.
AU - Simhan, Hyagriv N.
AU - Macones, George A.
N1 - Funding Information:
Supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (UG1 HD087230, UG1 HD027869, UG1 HD027915, UG1 HD034208, UG1 HD040500, UG1 HD040485, UG1 HD053097, UG1 HD040544, UG1 HD040545, UG1 HD040560, UG1 HD040512, UG1 HD087192, and U24 HD036801).
Publisher Copyright:
© 2023 Massachusetts Medical Society.
PY - 2023/4/13
Y1 - 2023/4/13
N2 - BACKGROUND: Prophylactic use of tranexamic acid at the time of cesarean delivery has been shown to decrease the calculated blood loss, but the effect on the need for blood transfusions is unclear.METHODS: We randomly assigned patients undergoing cesarean delivery at 31 U.S. hospitals to receive either tranexamic acid or placebo after umbilical-cord clamping. The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days post partum, whichever came first. Key secondary outcomes were estimated intraoperative blood loss of more than 1 liter (prespecified as a major secondary outcome), interventions for bleeding and related complications, the preoperative-to-postoperative change in the hemoglobin level, and postpartum infectious complications. Adverse events were assessed.RESULTS: A total of 11,000 participants underwent randomization (5529 to the tranexamic acid group and 5471 to the placebo group); scheduled cesarean delivery accounted for 50.1% and 49.2% of the deliveries in the respective groups. A primary-outcome event occurred in 201 of 5525 participants (3.6%) in the tranexamic acid group and in 233 of 5470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07; P = 0.19). Estimated intraoperative blood loss of more than 1 liter occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI, 0.79 to 1.05). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82 to 0.97); the change in the hemoglobin level was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI, 1.02 to 1.61). The frequencies of thromboembolic events and other adverse events were similar in the two groups.CONCLUSIONS: Prophylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT03364491.).
AB - BACKGROUND: Prophylactic use of tranexamic acid at the time of cesarean delivery has been shown to decrease the calculated blood loss, but the effect on the need for blood transfusions is unclear.METHODS: We randomly assigned patients undergoing cesarean delivery at 31 U.S. hospitals to receive either tranexamic acid or placebo after umbilical-cord clamping. The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days post partum, whichever came first. Key secondary outcomes were estimated intraoperative blood loss of more than 1 liter (prespecified as a major secondary outcome), interventions for bleeding and related complications, the preoperative-to-postoperative change in the hemoglobin level, and postpartum infectious complications. Adverse events were assessed.RESULTS: A total of 11,000 participants underwent randomization (5529 to the tranexamic acid group and 5471 to the placebo group); scheduled cesarean delivery accounted for 50.1% and 49.2% of the deliveries in the respective groups. A primary-outcome event occurred in 201 of 5525 participants (3.6%) in the tranexamic acid group and in 233 of 5470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07; P = 0.19). Estimated intraoperative blood loss of more than 1 liter occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI, 0.79 to 1.05). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82 to 0.97); the change in the hemoglobin level was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI, 1.02 to 1.61). The frequencies of thromboembolic events and other adverse events were similar in the two groups.CONCLUSIONS: Prophylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT03364491.).
KW - Complications of Pregnancy
KW - Obstetrics/Gynecology
KW - Obstetrics/Gynecology General
KW - Hemoglobins/analysis
KW - Tranexamic Acid/adverse effects
KW - Blood Loss, Surgical/mortality
KW - Humans
KW - Antifibrinolytic Agents/adverse effects
KW - Chemoprevention
KW - Cesarean Section/adverse effects
KW - Maternal Death
KW - Pregnancy
KW - Postpartum Hemorrhage/blood
KW - Blood Transfusion
KW - Female
KW - Child
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U2 - 10.1056/NEJMoa2207419
DO - 10.1056/NEJMoa2207419
M3 - Article
C2 - 37043652
AN - SCOPUS:85152335799
SN - 0028-4793
VL - 388
SP - 1365
EP - 1375
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 15
ER -