Epidemiology and Risk Factors of Uterine Fibroids in China

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Uterine Fibroid

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: WENWEN WANG, DOCTOR; Phone Number: 15927167698; Email: petrawang@163.com
• Study Contact Backup: Name: MINLI ZHANG, MASTER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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.

Description

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of uterine fibroids in China	Prevalence of uterine fibroids in China	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of uterine fibroids in China	Incidence of uterine fibroids in China	Two follow-ups over a three-year period
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

Collaborators and Investigators

• Sponsor: Shixuan Wang
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; West China Hospital; Tongji Hospital; Women's Hospital School Of Medicine Zhejiang University; Fourth Hospital of Shijiazhuang City
• Investigators: Principal Investigator: SHIXUAN WANG, DOCTOR, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): June 19, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: V2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No