The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid
研究概览
简要总结
Postpartum hemorrhage is the most common cause of maternal death across the world, responsible for more than 25% of maternal deaths annually. Although effective tools for prevention and treatment of are available, most are not feasible or practical for use in the developing world where many births still occur at home with untrained birth attendants . primary postpartum hemorrhage is excessive bleeding from or in the genital tract within 24 hours of delivery of the fetus which affects the general condition.
Postpartum hemorrhage is responsible for around 25% of maternal mortality worldwide , reaching as high as 60% in some countries. Postpartum hemorrhage can also be a cause of long-term severe morbidity, and approximately 12% of women who survive postpartum hemorrhagewill have severe anemia.
Tranexamic acid is an antifibrinolytic compound which is a potent competitive inhibitor of the activation of plasminogen to plasmin. At much higher concentrations it is a non-competitive inhibitor of plasmin. The inhibitory effect of tranexamic acid in plasminogen activation by urokinase has been reported to be 6-100 times and by streptokinase 6-40 times greater than that of aminocaproic acid.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women (37-42 weeks),
- •with spontaneous labor
- •Women who were expected to normal vaginal birth.
- •women with a live fetus.
排除标准
- •multiple gestations
- •polyhydramnios
- •macrocosmic baby
- •grand multipara
- •women with hypertensive disorders
- •previous history of postpartum hemorrhage
- •abnormal placentation (placenta previa or placental abruption)
- •history of any uterine scarring (including cesarean section)
- •history of blood/liver/renal/heart diseases.
研究组 & 干预措施
Tranexamic acid
received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period
干预措施: Tranexamic Acid (Drug)
Tranexamic acid
received tranexamic acid containing 1 g/10mL tranexamic acid diluted with 20 mL of 5% glucose over a 5 minute period
干预措施: 5% glucose (Drug)
placebo
received 30 mL of 5% glucose over the same period of time.
干预措施: 5% glucose (Drug)
结局指标
主要结局
The changes in Doppler indices of subendomterial blood vessels after use of tranexamic acid
时间窗: 6 month
The changes in Doppler indices of uterine artery after use of tranexamic acid
时间窗: 6 months
The changes in Doppler indices of intramyometrial blood vessels after use of tranexamic acid
时间窗: 6 months
次要结局
- The volume of blood loss after delivery (mL)(6 months)
- The hemoglobin concentration(6 months)
- Number of patients needed for blood transfusion(6 months)
- The hematocrit values (%)(6 months)
