Abstract：
BACKGROUND: Postpartum hemorrhage (PPH) is an obstetrical emergency that occurs in 1% to 10% of all deliveries and contributes to nearly one-quarter of all maternal deaths worldwide. Tranexamic acid has been established as an adjunct in the treatment of PPH but its role in its prevention of PPH following vaginal delivery has not been widely studied.
OBJECTIVE: This study aimed to assess the effect of prophylactic tranexamic acid (1 g) along with active management of the third stage of labor in reducing postpartum blood loss and the incidence of postpartum hemorrhage after vaginal delivery.
METHODS: In this randomized controlled trial, 650 women with singleton pregnancies at ≥34 weeks of gestation who were undergoing vaginal delivery were included. Eligible women were randomly assigned to receive either 1 g of tranexamic acid or placebo intravenously along with active management of the third stage of labor. Calibrated blood collection bags were used to measure postpartum blood loss during the third and fourth stages of labor.
RESULTS: Of 886 women approached for the study, 650 who met the inclusion criteria were enrolled, and 320 in group A and 321 in group B were analyzed. The maternal characteristics were similar between the groups. The mean blood loss did not differ significantly between the intervention and placebo groups (378.5±261.2 mL vs 383.0±258.9 mL; P=.93). The incidence of primary postpartum hemorrhage was comparable in both groups (15.9% in group A and 15.3% in group B; P=.814). The median quantitative decreases in hemoglobin levels within 12 to 24 hours after delivery were 0.60 g% (interquartile range, 0.40-0.90) in group A and 0.60 g% (interquartile range, 0.40-0.80) in group B, which were comparable in both groups (P=.95). The most common adverse effect reported was dizziness, and there was no thromboembolic event at 3 months follow-up in either group.
CONCLUSIONS: The use of tranexamic acid as a prophylactic measure along with active management of the third stage of labor does not provide additional benefit in reducing the postpartum blood loss and incidence of postpartum hemorrhage after vaginal delivery.
OBJECTIVE: This study aimed to assess the effect of prophylactic tranexamic acid (1 g) along with active management of the third stage of labor in reducing postpartum blood loss and the incidence of postpartum hemorrhage after vaginal delivery.
METHODS: In this randomized controlled trial, 650 women with singleton pregnancies at ≥34 weeks of gestation who were undergoing vaginal delivery were included. Eligible women were randomly assigned to receive either 1 g of tranexamic acid or placebo intravenously along with active management of the third stage of labor. Calibrated blood collection bags were used to measure postpartum blood loss during the third and fourth stages of labor.
RESULTS: Of 886 women approached for the study, 650 who met the inclusion criteria were enrolled, and 320 in group A and 321 in group B were analyzed. The maternal characteristics were similar between the groups. The mean blood loss did not differ significantly between the intervention and placebo groups (378.5±261.2 mL vs 383.0±258.9 mL; P=.93). The incidence of primary postpartum hemorrhage was comparable in both groups (15.9% in group A and 15.3% in group B; P=.814). The median quantitative decreases in hemoglobin levels within 12 to 24 hours after delivery were 0.60 g% (interquartile range, 0.40-0.90) in group A and 0.60 g% (interquartile range, 0.40-0.80) in group B, which were comparable in both groups (P=.95). The most common adverse effect reported was dizziness, and there was no thromboembolic event at 3 months follow-up in either group.
CONCLUSIONS: The use of tranexamic acid as a prophylactic measure along with active management of the third stage of labor does not provide additional benefit in reducing the postpartum blood loss and incidence of postpartum hemorrhage after vaginal delivery.
摘要：
目的：评估预防性氨甲环酸（1g）在减少阴道分娩后产后失血量和PPH发生率方面的作用，除了积极管理第三产程。
方法：在这项随机对照试验中，纳入650名接受阴道分娩的单胎妊娠≥34周的妇女。除了积极管理第三产程外，符合条件的妇女还被随机分配接受1g氨甲环酸或静脉注射安慰剂。在第三和第四分娩阶段，使用校准的采血袋测量产后失血量。
结果：在886名接受研究的女性中，650名符合入选标准的人被纳入，分析A组320例和B组321例。两组产妇的特征相似。平均失血量在干预组和安慰剂组之间没有显着差异（378.5±261.2ml与383±258.9ml；p=0.93）。两组的原发性产后出血发生率相当(A组:15.9%,B组：15.3%，p=0.814)。A组分娩后12-24小时内血红蛋白的中位数（四分位数间）定量下降为0.60g％（0.40-0.90），B组为0.60g％（0.40-0.80），两组具有可比性（p=0.95）。报告的最常见的不良反应是头晕，两组随访3个月时均无血栓栓塞事件。
结论：使用氨甲环酸作为预防措施，同时积极管理第三产程，在减少产后失血以及阴道分娩后PPH的发生率方面没有额外的益处。
方法：在这项随机对照试验中，纳入650名接受阴道分娩的单胎妊娠≥34周的妇女。除了积极管理第三产程外，符合条件的妇女还被随机分配接受1g氨甲环酸或静脉注射安慰剂。在第三和第四分娩阶段，使用校准的采血袋测量产后失血量。
结果：在886名接受研究的女性中，650名符合入选标准的人被纳入，分析A组320例和B组321例。两组产妇的特征相似。平均失血量在干预组和安慰剂组之间没有显着差异（378.5±261.2ml与383±258.9ml；p=0.93）。两组的原发性产后出血发生率相当(A组:15.9%,B组：15.3%，p=0.814)。A组分娩后12-24小时内血红蛋白的中位数（四分位数间）定量下降为0.60g％（0.40-0.90），B组为0.60g％（0.40-0.80），两组具有可比性（p=0.95）。报告的最常见的不良反应是头晕，两组随访3个月时均无血栓栓塞事件。
结论：使用氨甲环酸作为预防措施，同时积极管理第三产程，在减少产后失血以及阴道分娩后PPH的发生率方面没有额外的益处。
