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Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

Primary Purpose

Other Abnormal Uterine and Vaginal Bleeding

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

bilateral permanent occlusion of uterine arteries

About this trial

This is an interventional treatment trial for Other Abnormal Uterine and Vaginal Bleeding focused on measuring permenant occlusion, uterine bleeding, uterine arteries

Eligibility Criteria

34 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Mansoura Integrated fertility center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BUAO

Arm Description

The study done in two phases: Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients

Outcomes

Primary Outcome Measures

uterine bleeding

Secondary Outcome Measures

patient satisfaction

quality of life

Full Information

NCT ID

NCT05423067

First Posted

December 9, 2015

Last Updated

June 14, 2022

Sponsor

Mansoura Integrated Fertility Center

1. Study Identification

Unique Protocol Identification Number

NCT05423067

Brief Title

Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

Official Title

Interventional Gynecologic Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura Integrated Fertility Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Prospective observational interventional study , The study done in two phases: Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.

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: Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Other Abnormal Uterine and Vaginal Bleeding

Keywords

permenant occlusion, uterine bleeding, uterine arteries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BUAO

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

bilateral permanent occlusion of uterine arteries

Intervention Description

bilateral permanent Occlusion of uterine arteries through abdominal route

Primary Outcome Measure Information:

Title

uterine bleeding

Time Frame

October 2011 till January 2016

Secondary Outcome Measure Information:

Title

patient satisfaction

Time Frame

october 2011 - may 2015

Title

quality of life

Time Frame

october 2011 - may 2015

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

34 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adel S Helal, MD

Organizational Affiliation

Mansoura Integrated Fertility Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura Integrated fertility center

City

Mansoura

State/Province

Dekahlia

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

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