Sublingual Misoprostol With or Without Intravenous Tranexamic Acid During Hemorrhagic Cesarean Section

  • STATUS
    Recruiting
  • End date
    Jan 31, 2022
  • participants needed
    150
  • sponsor
    Aswan University Hospital
Updated on 22 January 2021

Summary

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.

Description

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

Details
Condition Cesarean Section Complications
Treatment misoprostol, Tranexamic Acid, placebo to tranexamic acid
Clinical Study IdentifierNCT03774706
SponsorAswan University Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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