Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy

Phase 4

• Conditions: Myomectomy
• Interventions: Drug: intravenous tranexamic acid; Drug: vaginal dinoprostone; Drug: vaginal placebo

• Registration Number: NCT04357002
• Lead Sponsor: Cairo University

Brief Summary

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

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: 2020-04-30
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous tranexamic acid	intravenous tranexamic acid	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 dinoprostone	vaginal dinoprostone	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
placebo	vaginal placebo	patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

Primary Outcome Measures

Name	Time	Method
intraoperative blood loss	one hour	estimation of intraoperative blood loss in ml

Secondary Outcome Measures

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