临床试验/NCT01085006

NCT01085006已完成1 期

The Effect of Tranexamic Acid Administration on Postpartum Hemorrhage During and After Cesarean Delivery

Tehran University of Medical Sciences1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2009年9月最近更新: 2011年1月25日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Tehran University of Medical Sciences
入组人数: 100
试验地点: 1
主要终点: The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别: Female
接受健康志愿者: 是

入选标准

•Term pregnancy
•Single fetus
•Maximally only one previous cesarean delivery

排除标准

•More than one previous cesarean delivery
•Hx of other abdominal or pelvic surgery
•Hx of medical disorders
•Hx of thromboembolic disorders
•Polyhydramnios
•Preeclampsia
•Hx of sensitivity to Tranexamic acid
•Abnormal Pt, PTT, PT or INR

研究组 & 干预措施

Tranexamic acid

Experimental

干预措施: Tranexamic acid (Drug)

normal saline infusion

Placebo Comparator

干预措施: Normal saline (Drug)

结局指标

主要结局

The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward

时间窗: During the procedure and within 2 hours afterwards

次要结局

Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery(First 24 hours)

研究者

发起方

Tehran University of Medical Sciences

申办方类型

Other

研究点 (1)

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