Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age

N/ANot Yet RecruitingNCT06055114

Lin Yuan300 enrolled

Overview

The study participants are patients with uterine fibroids and healthy physical examination subjects from the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital). The main purpose of this study is to analyze the correlation between uterine fibroids and vaginal microecology and cervical local immune function in patients of childbearing age.

(1) In this study, 150 women of childbearing age who are diagnosed with uterine fibroids in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) are selected as the study group; The differences of vaginal microenvironment and cervical local immune function are compared between 150 healthy women of childbearing age in the same period. (2) After the patients are enrolled, the general information (age, height, weight), menstrual status (age of menarche, menstrual period, cycle, bleeding pattern), clinical manifestations (abnormal uterine bleeding, infertility, abdominal pain), and previous medical history (hypertension, thyroid disease, etc.) of 150 patients with uterine fibroids will be collected. After the end of the first part of the experiment, 150 patients with uterine fibroids will be grouped according to vaginal microecological diagnosis, and the clinical characteristics of patients with uterine fibroids will be analyzed and compared.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Uterine Fibroids

Interventions

Microscopic examination of vaginal dischargeDIAGNOSTIC_TEST

Using gram-stained smears to detect vaginal secretions, and then the concentration and diversity of bacterial flora are observed using a microscope.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Study group inclusion criteria: * Age 20-49 years old * Premenopausal * Clinical diagnosis of uterine myoma * Cervical liquid-based cytology and human papillomavirus typing test are negative Healthy control group: * Age 20-49 years old * Premenopausal * Uterine B-ultrasonography is normal * Cervical liquid-based cytology and human papillomavirus typing test are negative * No vaginal infection Exclusion Criteria: Exclusion criteria of the study group: * Used antibiotics, hormones, immunosuppressants and regulators within 1 month * Sex, vaginal irrigation or applied medicine 3 days before the vaginal discharge sampling * Pregnant, lactating or menstruating women * Uterus and uterine adnexa have other lesions Exclusion criteria of healthy control group: * Used antibiotics, hormones, immunosuppressants and regulators within 1 month * Sex, vaginal irrigation or applied medicine 3 days before the vaginal discharge sampling * Pregnant, lactating or menstruating women

Outcomes

Primary Outcomes

Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group

Nugent score is currently an internationally accepted diagnostic method for BV. Lactobacillus, Gardnerella vaginalis, bacterioid bacteria and campylobacter with variable staining are evaluated by Gram staining and semi-quantitative evaluation method. The total score is the sum of the scores of the above 4 bacteria. 0 to 3 points: normal; 4 \~ 6 points: intermediate BV; ≥7 points: BV

Time frame: through study completion, an average of 2.5 year

Central Contacts

Lin Yuan, Ph.D.

CONTACT

0531-89269680 yuanl@sdfmu.edu.cn

Data from ClinicalTrials.gov

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