Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial

被引:7
|
作者
Sentilhes, Loic [1 ]
Madar, Hugo [1 ]
Le Lous, Maela [2 ]
Senat, Marie Victoire [3 ]
Winer, Norbert [4 ,5 ,6 ]
Rozenberg, Patrick [7 ]
Kayem, Gilles [8 ,9 ]
Verspyck, Eric [10 ]
Fuchs, Florent [11 ,12 ]
Azria, Elie [8 ,13 ]
Gallot, Denis [14 ]
Korb, Diane [15 ]
Desbriere, Raoul [16 ]
Le Ray, Camille [8 ,17 ]
Chauleur, Celine [18 ]
de Marcillac, Fanny [19 ]
Perrotin, Franck [20 ]
Parant, Olivier [21 ]
Salomon, Laurent J. [22 ]
Gauchotte, Emilie [23 ]
Bretelle, Florence [24 ]
Sananes, Nicolas [25 ]
Bohec, Caroline [26 ]
Mottet, Nicolas [27 ]
Legendre, Guillaume [28 ]
Letouzey, Vincent [29 ]
Haddad, Bassam [30 ]
Vardon, Delphine [31 ]
Mattuizzi, Aurelien [1 ]
Froeliger, Alizee [1 ]
Bouchghoul, Hanane [1 ]
Daniel, Valerie [32 ]
Regueme, Sophie [33 ]
Roussillon, Caroline [34 ]
Georget, Aurore [35 ]
Darsonval, Astrid [32 ]
Benard, Antoine [35 ]
Deneux-Tharaux, Catherine [8 ]
机构
[1] Bordeaux Univ Hosp, Dept Obstet & Gynecol, Bordeaux, France
[2] Rennes Univ Hosp, Dept Obstet & Gynecol, Rennes, France
[3] Bicetre Univ Hosp, Assistance Publ Hop Paris, Dept Obstet & Gynecol, Paris, France
[4] Univ Hosp Nantes, Dept Obstet & Gynecol, Univ Med Ctr Nantes, Ctr Invest Clin Mere Enfant, Nantes, France
[5] Univ Nantes, Unite Mixte Rech 1280, Physiol Nutr Adaptat, Natl Inst Agr Res,Inst Digest Dis, Nantes, France
[6] Ctr Rech Nutr Humaine Ouest, Nantes, France
[7] Poissy St Germain Hosp, Dept Obstet & Gynecol, Poissy, France
[8] Univ Paris, Univ Hosp Dept Risks Pregnancy, Inst Natl Rech Agron,Obstet Perinatal & Pediat Ep, Inst Natl Sante & Rech Med,Ctr Rech Epidemiol & S, Paris, France
[9] Trousseau Hosp, Assistance Publ Hop Paris, Dept Obstet & Gynecol, Paris, France
[10] Rouen Univ Hosp, Dept Obstet & Gynecol, Rouen, France
[11] Montpellier Univ Hosp, Dept Obstet & Gynecol, Villejuif, France
[12] Inst Natl Sante & Rech Med, Ctr Res Epidemiol & Populat Hlth, Reprod & Child Dev, U1018, Villejuif, France
[13] Paris Descartes Univ, Paris St Joseph Hosp, Matern Unit, Paris, France
[14] Clermont Ferrand Univ Hosp, Dept Obstet & Gynecol, Clermont Ferrand, France
[15] Robert Debre Hosp, Assistance Publ Hop Paris, Dept Obstet & Gynecol, Paris, France
[16] St Joseph Hosp, Dept Obstet & Gynecol, Marseille, France
[17] Univ Paris, Cochin Hosp, Assistance Publ Hop Paris, Port Royal Matern Unit,Fighting Prematur Univ Hos, Paris, France
[18] St Etienne Univ Hosp, Dept Obstet & Gynecol, St Etienne, France
[19] Univ Hosp Strasbourg, Dept Obstet & Gynecol, Strasbourg, France
[20] Tours Univ Hosp, Dept Obstet & Gynecol, Tours, France
[21] Toulouse Univ Hosp, Dept Obstet & Gynecol, Toulouse, France
[22] Necker Enfants Malad Hosp, Assistance Publ Hop Paris, Dept Obstet & Gynecol, Paris, France
[23] Nancy Univ Hosp, Dept Obstet & Gynecol, Nancy, France
[24] Aix Marseille Univ, Assistance Publ Hop Marseille, Dept Obstet & Gynecol, Marseille, France
[25] Hop Ctr Med Chirurg & Obstetr, Dept Obstet & Gynecol, Schiltigheim, France
[26] Francois Mitterrand Hosp, Dept Obstet & Gynecol, Pau, France
[27] Besancon Univ Hosp, Dept Obstet & Gynecol, Besancon, France
[28] Angers Univ Hosp, Dept Obstet & Gynecol, Angers, France
[29] Caremeau Univ Hosp, Dept Obstet & Gynecol, Nimes, France
[30] Univ Paris Est Creteil, Ctr Hosp Intercommunal Creteil, Dept Obstet Gynecol & Reprod Med, Creteil, France
[31] Caen Univ Hosp, Dept Obstet & Gynecol, Caen, France
[32] Brest Univ Hosp, Prod Pharmaceut Rech Inst Grand Ouest, Brest, France
[33] Bordeaux Univ Hosp, Dept Clin Res & Innovat, Bordeaux, France
[34] Bordeaux Univ Hosp, Dept Clin Res & Innovat, French Clin Res Infrastruct Network, European Clin Trials Platform & Dev, Bordeaux, France
[35] Ctr Hosp Univ Bordeaux, Publ Hlth Dept, Epidemiol Unit, Bordeaux, France
关键词
blood loss; cesarean delivery; multiple pregnancy; postpartum hemorrhage; prevention; tranexamic acid; PLACEBO-CONTROLLED-TRIAL; METAANALYSIS; GUIDELINES; LEVEL; RISK;
D O I
10.1016/j.ajog.2022.06.019
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
BACKGROUND: Although prophylactic tranexamic acid administration after cesarean delivery resulted in a lower incidence of calculated estimated blood loss of > 1000 mL or red cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery 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: This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies. STUDY DESIGN: This was a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial data, a double-blind, randomized controlled trial from March 2018 to January 2020 in 27 French maternity hospitals, that included 319 women with multiple pregnancies. Women with a cesarean delivery before or during labor at >= 34 weeks of gestation 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 of >1000 mL or a red blood cell transfusion by 2 days after delivery. The 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, and 298 (93.4%) had 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 (adjusted risk ratio, 0.97; 95% confidence interval, 0.68-1.38; P=.86). No significant between-group differences occurred for any hemorrhage-related clinical outcomes: gravimetrically estimated blood loss, provider-assessed clinically significant hemorrhage, additional uterotonics, postpartum blood transfusion, arterial embolization, and emergency surgery (P>.05 for all comparisons). CONCLUSION: Among women with a multiple pregnancy and cesarean delivery, prophylactic tranexamic acid did not reduce the incidence of any blood losserelated outcomes.
引用
收藏
页码:889.e1 / 889.e17
页数:17
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