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Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery.
Pacheco, Luis D; Clifton, Rebecca G; Saade, George R; Weiner, Steven J; Parry, Samuel; Thorp, John M; Longo, Monica; Salazar, Ashley; Dalton, Wendy; Tita, Alan T N; Gyamfi-Bannerman, Cynthia; Chauhan, Suneet P; Metz, Torri D; Rood, Kara; Rouse, Dwight J; Bailit, Jennifer L; Grobman, William A; Simhan, Hyagriv N; Macones, George A.
Afiliação
  • Pacheco LD; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Clifton RG; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Saade GR; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Weiner SJ; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Parry S; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Thorp JM; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Longo M; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Salazar A; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Dalton W; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Tita ATN; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Gyamfi-Bannerman C; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Chauhan SP; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Metz TD; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Rood K; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Rouse DJ; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Bailit JL; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Grobman WA; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Simhan HN; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
  • Macones GA; From the University of Texas Medical Branch, Galveston (L.D.P., G.R.S., A.S.), the University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston (S.P.C.), and the University of Texas at Austin, Austin (G.A.M.) - all in Texas; the George Washington University Bio
N Engl J Med ; 388(15): 1365-1375, 2023 Apr 13.
Article em En | MEDLINE | ID: mdl-37043652
ABSTRACT

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.).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ácido Tranexâmico / Cesárea / Hemorragia Pós-Parto / Antifibrinolíticos Tipo de estudo: Clinical_trials / Etiology_studies Limite: Child / Female / Humans / Pregnancy Idioma: En Revista: N Engl J Med Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ácido Tranexâmico / Cesárea / Hemorragia Pós-Parto / Antifibrinolíticos Tipo de estudo: Clinical_trials / Etiology_studies Limite: Child / Female / Humans / Pregnancy Idioma: En Revista: N Engl J Med Ano de publicação: 2023 Tipo de documento: Article