Tranexamic Acid Versus Vaginal Misoprostol in Abdominal Myomectomy

Cairo University162 enrolled

Overview

the aim of the present study is to evaluate safety and efficacy of tranexamic acid versus vaginal misoprostol in reducing intraoperative blood loss during abdominal myomectomy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

162

Conditions

Myomectomy

Interventions

intravenous tranexamic acidDRUG

patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.

vaginal misoprostolDRUG

patients will be given one vaginal misoprostol tablet (200 mcg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

placeboDRUG

patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * symptomatic fibroids candidate for abdominal myomectomy Exclusion Criteria: * myomas candidate for laparoscopic or hysteroscopic myomectomy and allergy or contraindications to misoprostol or tranexamic acid

Outcomes

Primary Outcomes

intraoperative blood loss

intraoperative blood loss will be estimated during open myomectomy in mL

Time frame: one hour

Central Contacts

AHMED SAMY

CONTACT

+201100681167 ahmedsamy8233@gmail.com

Data from ClinicalTrials.gov

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