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临床试验/NCT02678208
NCT02678208已完成2 期

The Effect of Tranexamic Acid on Uterine Blood Flow After Vaginal Delivery

Assiut University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

Other

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Dr

Assiut University

研究点 (1)

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