Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy

NCT ID: NCT04357015

Last Updated: 2020-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-10-20

Brief Summary

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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

Detailed Description

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Conditions

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Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

intravenous tranexamic acid

Intervention Type DRUG

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

intravenous carbetocin

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

Group Type ACTIVE_COMPARATOR

intravenous carbetocin

Intervention Type DRUG

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

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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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 Type DRUG

intravenous carbetocin

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

assistant professor obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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AHMED SAMY

Role: CONTACT

+201100681167

Other Identifiers

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tranexamic acid myomectomy

Identifier Type: -

Identifier Source: org_study_id

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