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Clinical Trials/NCT04357015
NCT04357015
Unknown
Phase 4

Comparative Safety and Efficacy of Intravenous Tranexamic Acid Versus IV Carbetocin in Reducing Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial

Cairo University0 sites153 target enrollmentMay 1, 2020

Overview

Phase
Phase 4
Intervention
intravenous carbetocin
Conditions
Myomectomy
Sponsor
Cairo University
Enrollment
153
Primary Endpoint
intraoperative blood loss
Last Updated
6 years ago

Overview

Brief Summary

the aim of the present study is to compare safety and efficacy of intravenous tranexamic acid versus IV carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
October 20, 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

  • women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to FIGO staging

Exclusion Criteria

  • women with Myoma FIGO staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid

Arms & Interventions

intravenous carbetocin

The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision

Intervention: intravenous carbetocin

placebo

the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision

Intervention: placebo

intravenous tranexamic acid

The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision

Intervention: intravenous tranexamic acid

Outcomes

Primary Outcomes

intraoperative blood loss

Time Frame: one hour

the intraoperative blood loss in ml will be estimated during the procedure

Secondary Outcomes

  • need for blood transfusion(24 hours)

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