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

Study Overview
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Brief Summary
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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.

Detailed Description
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(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.

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

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Diagnostic Test: Microscopic examination of vaginal discharge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>Age 20-49 years old; Premenopausal; Clinical diagnosis of uterine myoma; Cervical liquid-based cytology and human papillomavirus typing test are negative. | Diagnostic Test: Microscopic examination of vaginal discharge<br>* Using gram-stained smears to detect vaginal secretions, and then the concentration and diversity of bacterial flora are observed using a microscope.<br>|
| Healthy control group<br>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. | Diagnostic Test: Microscopic examination of vaginal discharge<br>* Using gram-stained smears to detect vaginal secretions, and then the concentration and diversity of bacterial flora are observed using a microscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through study completion, an average of 2.5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uterine fibroids, vaginal microecology, cervical local immune function, childbearing age