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Trial Title:
Epidemiology and Risk Factors of Uterine Fibroids in China
NCT ID:
NCT05840042
Condition:
Uterine Fibroid
Conditions: Official terms:
Leiomyoma
Myofibroma
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
Uterine fibroids are the most common form of benign uterine tumors in the uterine muscle
layer, which 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
investigators 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.
Criteria for eligibility:
Study pop:
This study population is women aged more than 18yrs with or without uterine fibroids from
five regions of China. The study time period will conduct from May 1, 2023 - November 30,
2025 to allow for 6 months pre-index for evaluating baseline demographic and clinical
characteristics and 24 months post-index, ensuring a minimum of one years follow-up.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Current place of residence≥ 6 months;
- No serious mental illness or mental abnormality;
- Those who agree to participate in this survey and cooperate in completing the
questionnaire.
Exclusion Criteria:
-
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
June 19, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shixuan Wang
Agency class:
Other
Collaborator:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
Fourth Hospital of Shijiazhuang City
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840042
