Impact of Misoprostol on Blood Loss In Myomectomy Operations

August 9, 2014 updated by: Dr.Ahmed Elnaggar, Ain Shams University

Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University, Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myomectomy, rectal Misoprostol
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.
Drug: Misoprostol
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation
Other Names:
  • Cytotec
Active Comparator: Myomectomy, Placebo
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
Drug: Placebo( for misoprostol)
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intraoperative blood loss
Time Frame: time from peritoneum opening till its closure around (1 Hour)
time from peritoneum opening till its closure around (1 Hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Abd El Mgeed I. Abd El Mgeed, Professor, Ain Shams University
  • Study Director: Mohamed S. Ali, Professor, Ain Shams University
  • Principal Investigator: Mohamed A. Abdel-Hafeez, Lecturer, Ain Shams University
  • Principal Investigator: Mina A. Yacoup, Fellow, Ain Shams University
  • Principal Investigator: Ahmed M. Elnaggar, Lecturer, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIN-1111-MM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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