South Miami Hospital Fibroid Registry

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.

Study Overview

• Status: Terminated
• Conditions: Uterine Myomas, Leiomyomas, or Fibromas

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • South Miami Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Outpatients seen for fibroid treatment services.

Description

Inclusion Criteria:

1. Patients seeking treatment for uterine myomas, leiomyomas, or fibromas.
2. Patients between the ages of 18-89.
3. Patients that agree to participate and sign consent.

Exclusion Criteria:

1)Patients that decline to participate and/or are younger than 18 or older than 89.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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?	Baseline prior procedure, at follow up for 30 days (± 5 days), 6 months (±5 days) and 12 months (± 5 days) post procedure.

Collaborators and Investigators

• Sponsor: Baptist Health South Florida
• Investigators: Principal Investigator: Jaime Sepulveda, M.D, Principal Investigator

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: February 7, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Myomas; Leiomyomas; Fibromas
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Neoplasms, Fibrous Tissue; Leiomyoma; Myofibroma; Fibroma
• Other Study ID Numbers: 13-099