Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy

Cairo University180 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

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 dinoprostoneDRUG

patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

vaginal 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: * patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid

Outcomes

Primary Outcomes

intraoperative blood loss

estimation of intraoperative blood loss in ml

Time frame: one hour

Secondary Outcomes

blood transfusion

need for intraoperative or postoperative blood transfusion

Time frame: 24 hours

Central Contacts

AHMED SAMY

CONTACT

+201100681167 ahmedsamy8233@gmail.com

Data from ClinicalTrials.gov

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