NCT02936661Unknown4 期
Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 6,700
- 主要终点
- postpartum hemorrhage
研究概览
简要总结
It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.
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
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •gestational week more than 37;
- •to delivery by cesarean section;
- •informed consent form signed
排除标准
- •Any known renal or liver disorders
- •History of venous or arterial thrombosis
- •Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker.
- •Do cesarean section because of active bleeding
研究组 & 干预措施
Tranexamic acid
Experimental
Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section
干预措施: Tranexamic Acid (Drug)
placebo
Placebo Comparator
NS 10ml IV in 2 minutes after the baby delivered during ceasarean section
干预措施: Placebo (Drug)
结局指标
主要结局
postpartum hemorrhage
时间窗: 24h after the cesarean section
次要结局
- the amount of postpartum bleeding(24h after the cesarean section)
研究者
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