Efficacy of intravenous tranexamic acid in reducing blood loss after elective cesarean section: a prospective, randomized, double-blind, placebo-controlled study.
We sought to determine the efficacy and safety of tranexamic acid (TA) in reducing blood loss during elective cesarean section (CS). We performed a randomized, double-blind, placebo-controlled study of 660 women who underwent elective CS. The patients were randomly selected to receive an intravenous infusion of either TA (1 g/10 mL in 20 mL of 5% glucose; N = 330) or 30 mL 5% glucose prior to surgery. The primary outcome was the estimated blood loss following CS. No demographic difference was observed between groups. The mean estimated blood loss was significantly lower in women treated with TA compared with women in the placebo group (499.9 ± 206.4 mL versus 600.7 ± 215.7 mL, respectively; P < 0.001), and the proportion of women in the TA group who had an estimated blood loss >1000 mL was significantly lower than in the placebo group (7 [2.1%] versus 19 [5.8%], respectively; relative risk [RR] 2.7; 95% confidence interval [CI] 1.1 to 6.3; P < 0.03). Furthermore, more women in the placebo group than in the TA group required additional uterotonic agents (48 [14.5%] versus 28 [8.5%], respectively; RR 1.7; 95% CI 1.1 to 2.6; P = 0.02). Maternal and neonatal outcomes did not differ significantly. TA significantly reduced bleeding during CS, the percentage of patients with blood loss >1000 mL, and the need for additional uterotonic agents. Furthermore, the incidence of thromboembolic events did not increase. Our results suggest that TA can be used safely and effectively to reduce CS bleeding.
Department of Obstetrics and Gynecology, Mardin Women and Children Hospital, Mardin, Turkey. maidenkemal@yahoo.com
Kemal
K
Gungorduk
Gokhan
G
Yıldırım
Osman
O
Asıcıoğlu
Ozgu Celıkkol
OC
Gungorduk
Sinem
S
Sudolmus
Cemal
C
Ark
D000328:Adult; D000933:Antifibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001034:Apgar Score; D001724:Birth Weight; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion; D002585:Cesarean Section / Q000009:adverse effects*; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D005260:Female; D006400:Hematocrit; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal / Q000706:statistics & numerical data; D057194:Intention to Treat Analysis; D007567:Jaundice, Neonatal / Q000209:etiology; D007902:Length of Stay; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011247:Pregnancy; D013997:Time Factors; D014148:Tranexamic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000933:Antifibrinolytic Agents; D006454:Hemoglobins; D014148:Tranexamic Acid