Sentilhes Loïc, Daniel Valérie, Darsonval Astrid, Deruelle Philippe, Vardon Delphine, Perrotin Franck, Le Ray Camille, Senat Marie-Victoire, Winer Norbert, Maillard Françoise, Deneux-Tharaux Catherine
Department of Obstetrics and Gynecology, Angers University Hospital, 4, rue Larrey, 49933, Angers, France.
Department of Pharmacy, Angers University Hospital, Angers, France.
BMC Pregnancy Childbirth. 2015 Jun 14;15:135. doi: 10.1186/s12884-015-0573-5.
Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Estimates of its incidence in the literature vary widely, from 3 % to 15 % of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective in preventing PPH. Tranexamic acid (TXA), an antifibrinolytic agent, has been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n = 10) and vaginal (n = 2) deliveries show that women who received TXA had significantly less postpartum blood loss without any increase in their rate of severe adverse effects. However, the quality of these trials was poor and they were not designed to test the effect of TXA on the reduction of PPH incidence. Large, adequately powered, multicenter randomized controlled trials are required before the widespread use of TXA to prevent PPH can be recommended.
A multicenter, double-blind, randomized controlled trial will be performed. It will involve 4000 women in labor for a planned vaginal singleton delivery, at a term ≥ 35 weeks. Treatment (either TXA 1 g or placebo) will be administered intravenously just after birth. Prophylactic oxytocin will be administered to all women. The primary outcome will be the incidence of PPH, defined by blood loss ≥500 mL, measured with a graduated collector bag. This study will have 80 % power to show a 30 % reduction in the incidence of PPH, from 10.0 % to 7.0 %.
In addition to prophylactic uterotonic administration, a complementary component of the management of third stage of labor acting on the coagulation process may be useful in preventing PPH. TXA is a promising candidate drug, inexpensive, easy to administer, and simple to add to the routine management of deliveries in hospitals. This large, adequately powered, multicenter, randomized placebo-controlled trial seeks to determine if the risk-benefit ratio favors the routine use of TXA after delivery to prevent PPH.
ClinicalTrials.gov NCT02302456 (November 17, 2014).
产后出血（PPH）是孕产妇死亡的主要原因，占全球孕产妇死亡总数的四分之一。文献中对其发病率的估计差异很大，占分娩总数的3%至15%。产后使用宫缩剂是唯一已被证明对预防产后出血有效的干预措施。氨甲环酸（TXA）是一种抗纤溶药物，已被研究作为宫缩剂预防产后出血的潜在有用补充，因为它已被证明可减少择期手术中的失血、创伤患者的出血以及月经量。剖宫产（n = 10）和阴道分娩（n = 2）后预防产后出血的随机对照试验表明，接受氨甲环酸的女性产后失血量显著减少，且严重不良反应发生率未增加。然而，这些试验的质量较差，且并非旨在测试氨甲环酸对降低产后出血发生率的效果。在推荐广泛使用氨甲环酸预防产后出血之前，需要进行大规模、有足够效力的多中心随机对照试验。
将进行一项多中心、双盲、随机对照试验。该试验将纳入4000名计划进行单胎阴道分娩、孕周≥35周的临产妇女。分娩后立即静脉注射治疗药物（1 g氨甲环酸或安慰剂）。所有妇女均给予预防性缩宫素。主要结局将是产后出血的发生率，定义为失血≥500 mL，通过刻度收集袋测量。本研究将有80%的把握度显示产后出血发生率降低30%，从10.0%降至7.0%。
除了预防性使用宫缩剂外，作用于凝血过程的第三产程管理的补充成分可能有助于预防产后出血。氨甲环酸是一种有前景的候选药物，价格低廉、易于给药，且易于添加到医院分娩的常规管理中。这项大规模、有足够效力的多中心、随机安慰剂对照试验旨在确定风险效益比是否有利于产后常规使用氨甲环酸预防产后出血。
ClinicalTrials.gov NCT02302456（2014年11月17日）。
