Clinical Trial: South Miami Hospital Fibroid Registry
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational [Patient Registry]
Official Title: South Miami Hospital Fibroid Registry
Brief Summary: The purpose of the Fibroid Registry is to provide a comprehensive database that captures patient characteristics, clinical outcomes and pot-treatment quality of life measures for patients treated for uterine fibroids. This database will serve as a platform for future comparative effectiveness and other health services research studies.
Detailed Summary:
The proposed research will be a prospective registry study of patients treated for uterine fibroids at the Fibroid Center located at South Miami Hospitals Center for Women and Infants.
Our objective is to establish the Fibroid Registry:
- To collect and review short, middle and long term clinical outcomes data that will help inform and facilitate the decision making process of clinicians and patients on the safest and most effective treatment for symptomatic uterine myomas, leiomyomas, or fibromas.
- To be able to critically evaluate the quality of procedures being performed and to ultimately establish a gold standard of care based upon patient and clinical outcomes and characteristics.
- To ultimately establish a gold standard of care based upon clinical outcomes and patient characteristics.
Sponsor: Baptist Health South Florida
Current Primary Outcome: Short, middle and long term clinical outcomes data that will help inform and facilitate the decision making process of clinicians and patients on the safest and most effective treatment for symptomatic uterine myomas, leiomyomas, or fibromas. [ Time Frame: Data elements will be collected at baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Critically evaluate quality of procedures being performed and ultimately establish a gold standard of care based upon patient, clinical outcomes and characteristics (Fibroid Questionnaire & Quality of Life Questionnaire) [ Time Frame: Baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure. ]
Such registry will enable us to address a number of research questions, for instance:
- Is uterine artery embolization (UAE) a safe treatment for leiomyomata?
- Is UAE an effective treatment for leiomyomata?
- What is the likelihood of symptom relief?
- How durable is the treatment?
- What is the likelihood that a woman who undergoes UAE and plans subsequent pregnancy will be able to conceive and deliver a subsequent intrauterine pregnancy?
- Are women choosing this procedure content with their selection?
- Are there certain patient subgroups at higher risk or that have an increased likelihood of treatment benefits?
Original Secondary Outcome: Same as current
Information By: Baptist Health South Florida
Dates:
Date Received: January 20, 2015
Date Started: February 2015
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017
