跳至主要内容
临床试验/NCT03774706
NCT03774706Unknown不适用

Role of Sublingual Misoprostol With or Without Intravenous Tranexamic Acid for Reducing Post-partum Hemorrhage During and After Hemorrhagic Cesarean Section: A Double-Blind Randomized Clinical Trial

Aswan University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
number of patients develop postpartum hemorrhage

研究概览

简要总结

Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section.

详细描述

Different uterotonic agents administration, mainly oxytocin, has been routinely used to reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies reported that oxytocin use in the setting of CS may result in maternal adverse effects, including hypotension and tachycardia., Therefore, investigating other therapeutic agents with lower adverse effects and higher efficacy is needed. Recently, a number of studies reported a correlation between fibrinogen decrease and cesarean-related hemorrhage. Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been introduced as a uterotonic agent for preventing PPH following CS. A recent study reported that oral or sublingual misoprostol is more effective than the placebo in reducing severe PPH, 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women who undergone elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
  • age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, CS with inferior segment incision, and spinal anesthesia.

排除标准

  • having an underlying disease (heart, liver, kidney, pulmonary, etc.),
  • eclampsia and severe preeclampsia
  • allergy to TA (such as known allergy or thromboembolic event during pregnancy) and misoprostol
  • coagulation disorders
  • refuse or unable to consent

研究组 & 干预措施

Misoprostol with TA

Active Comparator

two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv

干预措施: Misoprostol (Drug)

Misoprostol with TA

Active Comparator

two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv

干预措施: Tranexamic Acid (Drug)

Misoprostol with placebo to TA

Active Comparator

two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv

干预措施: Misoprostol (Drug)

Misoprostol with placebo to TA

Active Comparator

two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv

干预措施: placebo to tranexamic acid (Drug)

结局指标

主要结局

number of patients develop postpartum hemorrhage

时间窗: 6 hours post operative

calculation of number of patients develop postpartum hemorrhage

次要结局

  • intraoperative blood loss (ml)(during the operation)

研究者

发起方
Aswan University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

hany farouk

Principal Investigator

Aswan University Hospital

研究点 (1)

Loading locations...

相似试验