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Epidemiology and Risk Factors of Uterine Fibroids in China

Sponsor
Shixuan Wang (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05840042
Collaborator
Women's Hospital School Of Medicine Zhejiang University (Other), Tongji Hospital (Other), First Affiliated Hospital, Sun Yat-Sen University (Other), West China Second University Hospital, Sichuan University (Other), Fourth Hospital of Shijiazhuang City (Other)
20,000
Enrollment
44.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Uterine fibroids are the most common form of benign uterine tumors in the uterine muscle layer. They had a certain rate of malignancy, but it is rare. The prevalence of uterine fibroids estimates range from 4.5% to 68.6% depending on study population and diagnostic methodology. The prevalence of fibroids has been historically underestimated by epidemiologic studies which focused mainly on symptomatic women, leaving behind a large population of asymptomatic women and women who underreport their symptoms. What we don't know was which women who have fibroids will develop clinical symptoms and which women who have an operation of myomectomy will relapse. The purpose of this study is to investigate the prevalence, incidence and risk factors for the development of uterine fibroids in Chinese women.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Epidemiology and Risk Factors of Uterine Fibroids in China
    Anticipated Study Start Date :
    Apr 21, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of uterine fibroids in China [Baseline]

      Prevalence of uterine fibroids in China

    Secondary Outcome Measures

    1. Incidence of uterine fibroids in China [Two follow-ups over a three-year period]

      Incidence of uterine fibroids in China

    2. Risk factors of development of uterine fibroids in China [Two follow-ups over a three-year period]

      Risk factors of development of uterine fibroids in China

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 69 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Current place of residence≥ 6 months;

    2. No serious mental illness or mental abnormality;

    3. Those who agree to participate in this survey and cooperate in completing the questionnaire.

    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shixuan Wang
    • Women's Hospital School Of Medicine Zhejiang University
    • Tongji Hospital
    • First Affiliated Hospital, Sun Yat-Sen University
    • West China Second University Hospital, Sichuan University
    • Fourth Hospital of Shijiazhuang City

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shixuan Wang, Professor, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT05840042
    Other Study ID Numbers:
    • V2.0
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma

    Study Results

    No Results Posted as of May 3, 2023