Epidemiology and Risk Factors of Uterine Fibroids in China

Uterine Fibroid Clinical Trial

Official title:

Epidemiology and Risk Factors of Uterine Fibroids in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05840042
• Other study ID #: V2.0
• Status: Not yet recruiting
• Start date: June 19, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Tongji Hospital
• Contact: WENWEN WANG, DOCTOR
• Phone: 15927167698
• Email: petrawang[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Locations

Country	Name	City	State
n/a

Sponsors (6)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of uterine fibroids in China	Prevalence of uterine fibroids in China	Baseline
Secondary	Incidence of uterine fibroids in China	Incidence of uterine fibroids in China	Two follow-ups over a three-year period
Secondary	Risk factors of development of uterine fibroids in China	Associated risk factors for recurrence, infertility and malignancy of uterine fibroids in China	Two follow-ups over a three-year period