Impact of Misoprostol on Blood Loss In Myomectomy Operations

Phase 3

Completed

• Conditions: Leiomyoma
• Interventions: Drug: Placebo( for misoprostol); Drug: Misoprostol

• Registration Number: NCT02061657
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications

Detailed Description

This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital.

A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial.

The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Primary Completion: 2014-06
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-08-09
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Premenopausal patients aged between 35 to 50 years old.
• Five or less symptomatic uterine myomas .
• Maximum diameter of the largest myoma is 6 cm .
• All myomas are subserous or intramural.
• Uterine size less than 24 weeks pregnancy

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Exclusion Criteria

• History of previous surgery.
• Allergy to Misoprostol.
• Hypertension.
• Cardiac and Pulmonary diseases.
• Patients who have bleeding disorders.
• Anemia (Hb < 10g %).
• Chronic endocrine or metabolic diseases such as Diabetes.
• Obesity (body mass index > 30 kg/m2).
• Cases that will require intraoperative conversion of myomectomy to hysterectomy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myomectomy, Placebo	Placebo( for misoprostol)	Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
Myomectomy, rectal Misoprostol	Misoprostol	25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.

Primary Outcome Measures

Name	Time	Method
intraoperative blood loss	time from peritoneum opening till its closure around (1 Hour)

Trial Locations

Locations (1)

Ain Shams University, Maternity Hospital; 🇪🇬 Cairo, Egypt