Kashanian Maryam, Dadkhah Farideh, Tabatabaei Nasim, Sheikhansari Narges
Department of Obstetrics & Gynecology, Akbarabadi Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran.
Department of Obstetrics & Gynecology, Firoozgar Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran.
J Matern Fetal Neonatal Med. 2022 Dec;35(25):5611-5615. doi: 10.1080/14767058.2021.1888911. Epub 2021 May 23.
Postpartum hemorrhage (PPH) is the most important concern after delivery. Tranexamic acid (TXA), an anti-fibrinolytic agent, has been suggested for prevention and treatment of PPH.
The purpose of the present study was to find the effects of TXA on the amount of bleeding following vaginal delivery and its adverse effects.
The study was performed as a randomized double blind placebo controlled clinical trial on low risk pregnant women who delivered vaginally. The patients were randomly assigned into two groups. Women in the intervention group received 10 mg/kg infusion of TXA in 100 mL normal saline and the control group received one vial of distilled water (as placebo) in 100 mL normal saline. The primary outcome was amount of bleeding after delivery. The secondary outcomes were decreased in hemoglobin level, need for additional uterotonic agents and need for blood transfusion. All were evaluated 6 h after delivery and compared in the two groups. Participants were followed up to six weeks after delivery for any TXA side effects.
Two hundred and seven women finished the study. There were no significant differences between the two groups in terms of demographic data and risk factors for bleeding. Mean blood loss and need to misoprostol was more in the control group (=.033 and =.000, respectively). Hemoglobin level was higher in the TXA group 6 h after delivery. None of the subjects needed blood transfusion, uterine balloon tamponade or emergency hysterectomy. Adverse effects were higher in the TXA group, however, there were no side effects between weeks 3 and 6 in both groups. There were no thromboembolic events during six weeks after delivery.
Tranexamic acid can reduce the amount of bleeding after vaginal delivery in low risk women without having serious complications. Also, it may decrease the need for additional uterotonic agents. Trial registration number and registry website: IRCT20091023002624N22.
产后出血（PPH）是分娩后最重要的关注点。氨甲环酸（TXA），一种抗纤溶药物，已被建议用于预防和治疗产后出血。
本研究的目的是探讨氨甲环酸对阴道分娩后出血量的影响及其不良反应。
本研究作为一项随机双盲安慰剂对照临床试验，针对经阴道分娩的低风险孕妇进行。患者被随机分为两组。干预组女性接受10mg/kg氨甲环酸溶于100mL生理盐水中的静脉输注，对照组接受100mL生理盐水中的一瓶蒸馏水（作为安慰剂）。主要结局是分娩后的出血量。次要结局包括血红蛋白水平下降、额外使用宫缩剂的需求以及输血需求。所有这些指标均在分娩后6小时进行评估，并在两组之间进行比较。参与者在分娩后随访六周，观察是否有氨甲环酸的副作用。
207名女性完成了研究。两组在人口统计学数据和出血风险因素方面无显著差异。对照组的平均失血量和米索前列醇的使用需求更多（分别为P = 0.033和P = 0.000）。分娩后6小时，氨甲环酸组的血红蛋白水平更高。没有受试者需要输血、子宫球囊压迫或紧急子宫切除术。氨甲环酸组的不良反应更多，然而，两组在第3周和第6周之间均无副作用。分娩后六周内没有血栓栓塞事件。
氨甲环酸可减少低风险女性阴道分娩后的出血量，且无严重并发症。此外，它可能减少额外使用宫缩剂的需求。试验注册号和注册网站：IRCT20091023002624N22。
