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Completed

NCT Number: NCT05423067

Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding

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.

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Key information

Age range

34 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mansoura Integrated fertility center

Al Mansurah, Dekahlia, Egypt

About this study

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:

  • 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral permanent occlusion of uterine arteries

Procedure

bilateral permanent Occlusion of uterine arteries through abdominal route

Primary outcomes

  1. uterine bleeding

    Time frame: October 2011 till January 2016

Secondary outcomes

  1. patient satisfaction

    Time frame: october 2011 - may 2015

  2. quality of life

    Time frame: october 2011 - may 2015

Sponsors and collaborators

Lead sponsor

Mansoura Integrated Fertility Center

Other

Registry information

Official study title

Interventional Gynecologic Surgery

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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