Tranexamic Acid Versus Vaginal Misoprostol in Abdominal Myomectomy

Phase 4

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

• Registration Number: NCT04358965
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Study Start: 2020-05-10
• Primary Completion: 2020-10-10
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous tranexamic acid	intravenous tranexamic acid	patients were given a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision plus one vaginal placebo tablet 1 hour before skin incision
vaginal misoprostol	vaginal misoprostol	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
placebo	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	intraoperative blood loss will be estimated during open myomectomy in mL