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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06055114
Enrollment
300
Registered
2023-09-26
Start date
2023-10-09
Completion date
2026-10-09
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids

Keywords

uterine fibroids, vaginal microecology, cervical local immune function, childbearing age

Brief summary

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

(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.

Interventions

DIAGNOSTIC_TESTMicroscopic examination of vaginal discharge

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

Sponsors

Lin Yuan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each groupthrough study completion, an average of 2.5 yearNugent 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

Contacts

Primary ContactLin Yuan, Ph.D.
yuanl@sdfmu.edu.cn0531-89269680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026