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Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy

Phase 4
Conditions
Myomectomy
Interventions
Drug: intravenous tranexamic acid
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

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
GroupInterventionDescription
intravenous tranexamic acidintravenous tranexamic acidThe tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision
intravenous carbetocinintravenous carbetocinThe carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision
placeboplacebothe placebo group will be given a normal saline IV bolus 20 minutes before surgical incision
Primary Outcome Measures
NameTimeMethod
intraoperative blood lossone hour

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

Secondary Outcome Measures
NameTimeMethod
need for blood transfusion24 hours

need for intraoperative or postoperative blood transfusion

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