Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy

Phase 4

• Conditions: Myomectomy
• Interventions: Drug: intravenous tranexamic acid; Drug: intravenous carbetocin; Drug: placebo

• Registration Number: NCT04357015
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22
• Study Start: 2020-05-01
• Primary Completion: 2020-10-10
• Study Completion: 2020-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous tranexamic acid	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
intravenous carbetocin	intravenous carbetocin	The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision
placebo	placebo	the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision

Primary Outcome Measures

Name	Time	Method
intraoperative blood loss	one hour	the intraoperative blood loss in ml will be estimated during the procedure

Secondary Outcome Measures

Name	Time	Method
need for blood transfusion	24 hours	need for intraoperative or postoperative blood transfusion