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临床试验/NCT04549012
NCT04549012Unknown早期 1 期

Tranexamic Acid Plus Oxytocin Versus Oxtocin Only in Reducing Blood Loss After Cesarean Section

Ain Shams University0 个研究点目标入组 130 人开始时间: 2020年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
130
主要终点
amount of blood loss

研究概览

简要总结

Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS

详细描述

tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS

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
Triple (Participant, Care Provider, Investigator)

盲法说明

women will be given serial number ,randomization will be done through a computer generated system

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

  • Age : 20-40 year
  • 2- Gestational age is between 37-41weeks
  • 3- Delivery by uncomplicated elective CS

排除标准

  • 1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),

研究组 & 干预措施

group A

Active Comparator

will receive oxytocin

干预措施: Oxytocin (Drug)

group B

Active Comparator

will receive tranexamic acid plus oxytocin

干预措施: Tranexamic acid (Drug)

结局指标

主要结局

amount of blood loss

时间窗: baseline

comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS

次要结局

  • maternal and neonatal complication(baseline)

研究者

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

Noha Mahmoud Abu Shata

egypt

Ain Shams University

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