Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

Other Abnormal Uterine and Vaginal Bleeding Clinical Trial

Official title:

Interventional Gynecologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423067
• Other study ID #: Adelhelal
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2011
• Est. completion date: May 2015

Study information

• Verified date: June 2022
• Source: Mansoura Integrated Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 2015
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 34 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Other Abnormal Uterine and Vaginal Bleeding
• Uterine Hemorrhage

Intervention

Procedure:
• bilateral permanent occlusion of uterine arteries
bilateral permanent Occlusion of uterine arteries through abdominal route

Locations

Country	Name	City	State
Egypt	Mansoura Integrated fertility center	Mansoura	Dekahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura Integrated Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uterine bleeding		October 2011 till January 2016
Secondary	patient satisfaction		october 2011 - may 2015
Secondary	quality of life		october 2011 - may 2015