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
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
- 否
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
two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv
干预措施: Misoprostol (Drug)
Misoprostol with TA
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
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
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
hany farouk
Principal Investigator
Aswan University Hospital
