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Clinical Trials/NCT04358965
NCT04358965
Unknown
Phase 4

Evaluating Safety and Efficacy of Tranexamic Acid Versus Vaginal Misoprostol in Reducing Intraoperative Blood Loss During Abdominal Myomectomy

Cairo University0 sites162 target enrollmentMay 10, 2020

Overview

Phase
Phase 4
Intervention
intravenous tranexamic acid
Conditions
Myomectomy
Sponsor
Cairo University
Enrollment
162
Primary Endpoint
intraoperative blood loss
Last Updated
6 years ago

Overview

Brief Summary

the aim of the present study is to evaluate safety and efficacy of tranexamic acid versus vaginal misoprostol in reducing intraoperative blood loss during abdominal myomectomy

Registry
clinicaltrials.gov
Start Date
May 10, 2020
End Date
October 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Samy aly ashour

assistant professor obstetrics and gynecology

Cairo University

Eligibility Criteria

Inclusion Criteria

  • symptomatic fibroids candidate for abdominal myomectomy

Exclusion Criteria

  • myomas candidate for laparoscopic or hysteroscopic myomectomy and allergy or contraindications to misoprostol or tranexamic acid

Arms & Interventions

intravenous tranexamic acid

patients were given a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision plus one vaginal placebo tablet 1 hour before skin incision

Intervention: intravenous tranexamic acid

vaginal misoprostol

patients will be given one vaginal misoprostol tablet (200 mcg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

Intervention: vaginal misoprostol

placebo

patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

Intervention: placebo

Outcomes

Primary Outcomes

intraoperative blood loss

Time Frame: one hour

intraoperative blood loss will be estimated during open myomectomy in mL

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