Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

Sponsor
Mansoura Integrated Fertility Center (Other)
Overall Status
Completed
CT.gov ID
NCT05423067
Collaborator
(none)
116
1
1
43
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: bilateral permanent occlusion of uterine arteries
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
116 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Interventional Gynecologic Surgery
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: BUAO

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

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

Outcome Measures

Primary Outcome Measures

  1. uterine bleeding [October 2011 till January 2016]

Secondary Outcome Measures

  1. patient satisfaction [october 2011 - may 2015]

  2. quality of life [october 2011 - may 2015]

Eligibility Criteria

Criteria

Ages Eligible for Study:
34 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura Integrated fertility center Mansoura Dekahlia Egypt

Sponsors and Collaborators

  • Mansoura Integrated Fertility Center

Investigators

  • Principal Investigator: Adel S Helal, MD, Mansoura Integrated Fertility Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emad Mohamad Sedeek, professor, Mansoura Integrated Fertility Center
ClinicalTrials.gov Identifier:
NCT05423067
Other Study ID Numbers:
  • Adelhelal
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Emad Mohamad Sedeek, professor, Mansoura Integrated Fertility Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022