Tranexamic acid in preventing postpartum blood loss in vaginal delivery: a double-blinded randomized controlled trial

IF 3.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY
Pratibha Arya MD, Garima Yadav MS, Pratibha Singh MD, Navdeep Kaur Ghuman MD, Charu Sharma MD, Meenakshi Gothwal MD, Priyanka Kathuria MD
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引用次数: 0

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.

STUDY DESIGN

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.

Conclusion

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.

氨甲环酸预防阴道分娩产后失血--一项双盲随机对照试验。
目的评估在积极处理第三产程的同时,预防性使用氨甲环酸(1 克)对减少产后失血和阴道分娩后 PPH 发生率的效果:在这项随机对照试验中,共纳入了 650 名妊娠期≥ 34 周、经阴道分娩的单胎孕妇。符合条件的产妇被随机分配到在积极处理第三产程的同时静脉注射1克氨甲环酸或安慰剂。使用校准采血袋测量第三和第四产程的产后失血量:在接受研究的 886 名产妇中,有 650 名符合纳入标准,A 组有 320 名,B 组有 321 名。两组产妇的特征相似。干预组和安慰剂组的平均失血量无明显差异(378.5±261.2 毫升 vs. 383±258.9 毫升;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 组产后 12-24 小时内血红蛋白定量下降的中位数(四分位间)为 0.60 g%(0.40-0.90),B 组为 0.60 g%(0.40-0.80),两组数据相当(P=0.95)。最常见的不良反应是头晕,两组随访三个月均未发生血栓栓塞事件:结论:使用氨甲环酸作为预防措施,同时积极处理第三产程,并不能在减少产后失血量和阴道分娩后 PPH 的发生率方面带来额外的益处。
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来源期刊
CiteScore
7.40
自引率
3.20%
发文量
254
审稿时长
40 days
期刊介绍: The American Journal of Obstetrics and Gynecology (AJOG) is a highly esteemed publication with two companion titles. One of these is the American Journal of Obstetrics and Gynecology Maternal-Fetal Medicine (AJOG MFM), which is dedicated to the latest research in the field of maternal-fetal medicine, specifically concerning high-risk pregnancies. The journal encompasses a wide range of topics, including: Maternal Complications: It addresses significant studies that have the potential to change clinical practice regarding complications faced by pregnant women. Fetal Complications: The journal covers prenatal diagnosis, ultrasound, and genetic issues related to the fetus, providing insights into the management and care of fetal health. Prenatal Care: It discusses the best practices in prenatal care to ensure the health and well-being of both the mother and the unborn child. Intrapartum Care: It provides guidance on the care provided during the childbirth process, which is critical for the safety of both mother and baby. Postpartum Issues: The journal also tackles issues that arise after childbirth, focusing on the postpartum period and its implications for maternal health. AJOG MFM serves as a reliable forum for peer-reviewed research, with a preference for randomized trials and meta-analyses. The goal is to equip researchers and clinicians with the most current information and evidence-based strategies to effectively manage high-risk pregnancies and to provide the best possible care for mothers and their unborn children.
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