Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

June 14, 2022 updated by: Emad Mohamad Sedeek, Mansoura Integrated Fertility Center

Interventional Gynecologic Surgery

Prospective observational interventional study , The study done in two phases:

  1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
  2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine arteries in treatment of abnormal uterine bleeding.

Design: prospective observational study Setting: Done in Mansoura university hospital, department of Obstetrics and gynecology.

Patients and Methods: The study done in two phases:

  1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
  2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.

Results: Results are hopeful and courageous in phase one as regards patients satisfaction, Quality of life and improvements of bleeding. Results of phase two will be implemented, analyzed and presented in tables. All data will be statistically analyzed and the results will be presented after completion of eighteen (18) months follow up to rule out any bias and/ or errors in the results.

Conclusion: permanent bilateral uterine arteries occlusion may be a good alternative to radical surgery in abnormal uterine bleeding.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2
  • Phase 1

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
    • Dekahlia
      • Mansoura, Dekahlia, Egypt
        • Mansoura Integrated Fertility Center

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

34 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • premenopausal with abnormal uterine bleeding and completed their families having normal endometrium (biopsy in preceding 6 months ) and may have uterine intramural myomas not exceeding 150 ml in volume and away from uterine cavity by at least 1cm and /or adenomyosis

Exclusion Criteria:

  • patients wishing future fertility
  • endometrial sampling not done or more than 6 months or myoma encroaching or distorting cavity or larger than 150 ml in volume

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: BUAO

The study done in two phases:

  1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
  2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients
Procedure: bilateral permanent occlusion of uterine arteries
bilateral permanent Occlusion of uterine arteries through abdominal route

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
uterine bleeding
Time Frame: October 2011 till January 2016
October 2011 till January 2016

Secondary Outcome Measures

Outcome Measure
Time Frame
patient satisfaction
Time Frame: october 2011 - may 2015
october 2011 - may 2015
quality of life
Time Frame: october 2011 - may 2015
october 2011 - may 2015

Collaborators and Investigators

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

Sponsor

Mansoura Integrated Fertility Center

Investigators

  • Principal Investigator: Adel S Helal, MD, Mansoura Integrated Fertility Center

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

October 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adelhelal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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