A Prospective, Ultrasound-Based Study to Evaluate Risk Factors for Uterine Fibroid Incidence and Growth: Methods and Results of Recruitment

Background: Uterine fibroids are common, benign, smooth-muscle tumors that can cause major morbidity for reproductive-age women, often requiring invasive treatment. Despite this personal and public health burden, no prior study has attempted to periodically screen fibroid-free women with ultrasound to detect incident disease and identify risk factors.

Methods: We designed a study to prospectively investigate development of fibroids by enrolling women without a clinical diagnosis of fibroids and screening for fibroids with ultrasound at baseline. Enrollment procedures included extensive questionnaires and specimen collection (blood, urine, vaginal swabs). The cohort is followed at approximately 20-month intervals. At each follow-up there are updates to the questionnaire data, further specimen collection, and an ultrasound examination. We identify incident disease and measure tumor growth. The two exposures of primary interest are vitamin D insufficiency and reproductive tract infections. This manuscript provides a detailed description of the study methods, recruitment results, and participant characteristics.

Results: The Study of Environment, Lifestyle and Fibroids enrolled 1,696 African American women aged 23-34 years. "Family and friends" was a leading recruitment source. More than 95% of participants contributed all the requested biological specimens at baseline. Study ultrasound examinations revealed undiagnosed fibroids in 378 women (22% of participants). The retention rate for the first follow-up was 87%.

Conclusions: Study design aspects likely to be important for long-term studies in young African Americans include personalized recruitment, multiple steps to the enrollment process that rely on the initiative of the participant, and methods for tracing highly mobile study subjects.