Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

Mansoura Integrated Fertility Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Other Abnormal Uterine and Vaginal Bleeding

Treatments: Procedure: bilateral permanent occlusion of uterine arteries

Study type: Interventional

Funder types: Other

Identifiers

NCT05423067

Adelhelal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: Female

Ages: 34 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

BUAO

Other group

Description:

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

Treatment:

Procedure: bilateral permanent occlusion of uterine arteries