TRAP2 - 氨甲环酸预防剖宫产产后出血多中心随机双盲安慰剂对照试验 - 研究方案。
TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol.
机构信息
Department of Obstetrics and Gynecology, Bordeaux University Hospital, Place Amélie Raba Léon, 33076, Bordeaux, France.
Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest (PPRIGO), Brest, France.
出版信息
BMC Pregnancy Childbirth. 2020 Jan 31;20(1):63. doi: 10.1186/s12884-019-2718-4.
BACKGROUND
An antifibrinolytic agent that blocks lysine-binding sites on plasminogen molecules, tranexamic acid reduces bleeding-related mortality in women with postpartum hemorrhage (PPH), especially administered fairly soon after delivery. According to the randomized controlled trials thus far reported for PPH prevention after cesarean deliveries (n = 16), women who received tranexamic acid had significantly less postpartum blood loss and no increase in severe adverse effects. These were, however, primarily small single-center studies that had fundamental methodological flaws. Multicenter randomized controlled trials with adequate power are necessary to demonstrate its value persuasively before tranexamic acid goes into widespread use for the prevention of PPH after cesarean deliveries.
METHODS/DESIGN: This study will be a multicenter, double-blind, randomized controlled trial with two parallel groups including 4524 women with cesarean deliveries before or during labor, at a term ≥34 weeks, modeled on our previous study of tranexamic acid administered after vaginal deliveries. Treatment (either tranexamic acid 1 g or placebo) will be administered intravenously just after birth. All women will also receive a prophylactic uterotonic agent. The primary outcome will be the incidence of PPH, defined by a calculated estimated blood loss > 1000 mL or a red blood cell transfusion before day 2 postpartum. This study will have 80% power to show a 20% reduction in the incidence of PPH, from 15.0 to 12.0%.
DISCUSSION
As an, inexpensive, easy to administer drug that can be add to the routine management of cesarean births in delivery rooms, tranexamic acid is a promising candidate for preventing PPH after these births. This large, adequately powered, multicenter randomized placebo-controlled trial seeks to determine if the benefits of the routine prophylactic use of tranexamic acid after cesarean delivery significantly outweigh its risks.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03431805 (February 12, 2018).
背景
氨甲环酸是一种抗纤维蛋白溶解剂，可阻断纤溶酶原分子上的赖氨酸结合位点，它可降低产后出血（PPH）产妇的出血相关死亡率，尤其是在分娩后相当短的时间内使用。根据迄今为止报告的用于剖宫产产后预防 PPH 的随机对照试验（n=16），接受氨甲环酸治疗的女性产后出血量明显减少，且严重不良事件没有增加。然而，这些主要是规模较小的单中心研究，存在根本的方法学缺陷。有必要开展多中心随机对照试验，以充分的效力证明氨甲环酸在广泛用于预防剖宫产产后 PPH 之前具有价值。
方法/设计：本研究将是一项多中心、双盲、随机对照试验，包括 4524 例在产程中或产程前行剖宫产的足月（≥34 周）产妇，采用我们之前关于阴道分娩后给予氨甲环酸的研究模式。治疗（氨甲环酸 1g 或安慰剂）将在分娩后立即静脉给药。所有女性还将接受预防性子宫收缩剂。主要结局为 PPH 的发生率，通过计算估计出血量>1000mL 或产后第 2 天前输血定义。本研究有 80%的效能显示 PPH 发生率降低 20%，从 15.0%降至 12.0%。
讨论
作为一种廉价、易于管理且可添加到产房剖宫产常规管理中的药物，氨甲环酸是预防这些分娩后 PPH 的有前途的候选药物。这项大型、充分有力、多中心随机安慰剂对照试验旨在确定常规预防性使用氨甲环酸是否显著超过其风险。
试验注册
ClinicalTrials.gov NCT03431805（2018 年 2 月 12 日）。
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