Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

Phase 1

Completed

• Conditions: Other Abnormal Uterine and Vaginal Bleeding
• Interventions: Procedure: bilateral permanent occlusion of uterine arteries

• Registration Number: NCT05423067
• Lead Sponsor: Mansoura Integrated Fertility Center

Brief Summary

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.

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 Timeline

• Study Start: 2011-10
• Primary Completion: 2012-10
• Study Completion: 2015-05
• Study First Submitted: 2015-12-09
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-14
• Last Update Submitted: 2022-06-14
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BUAO	bilateral permanent occlusion of uterine arteries	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

Primary Outcome Measures

Name	Time	Method
uterine bleeding	October 2011 till January 2016

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	october 2011 - may 2015
quality of life	october 2011 - may 2015

Trial Locations

Locations (1)

Mansoura Integrated fertility center; 🇪🇬 Mansoura, Dekahlia, Egypt