Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Myomectomy

Treatments: Drug: intravenous tranexamic acid; Drug: placebo; Drug: intravenous carbetocin

Study type: Interventional

Funder types: Other

Identifiers

NCT04357015

tranexamic acid myomectomy

Details and patient eligibility

About

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

Enrollment: 153 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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153 participants in 3 patient groups, including a placebo group

intravenous tranexamic acid

Experimental group

Description:

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

Treatment:

Drug: intravenous tranexamic acid

intravenous carbetocin

Active Comparator group

Description:

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

Treatment:

Drug: intravenous carbetocin

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo