Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

NCT05423067 | Completed Phase 1 DMC

• 1 other identifier: Adelhelal
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Other Abnormal Uterine and Vaginal Bleeding

Keywords

permenant occlusion; uterine bleeding; uterine arteries

Outcome Measures

Primary Outcomes (1)

• uterine bleeding

  October 2011 till January 2016

Secondary Outcomes (2)

• patient satisfaction

  october 2011 - may 2015

• quality of life

  october 2011 - may 2015

Study Arms (1)

BUAO

OTHER

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

Interventions

bilateral permanent occlusion of uterine arteries PROCEDURE

bilateral permanent Occlusion of uterine arteries through abdominal route

BUAO

Eligibility Criteria

• Age: 34 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura Integrated Fertility Center: lead

Study Sites (1)

Mansoura Integrated fertility center

Al Mansurah, Dekahlia, Egypt

Location

MeSH Terms

Conditions

Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adel S Helal, MD

  Mansoura Integrated Fertility Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: June 21, 2022
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: May 1, 2015
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

EG (1)