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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-49
SponsorLin Yuan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 20-49 years old

Premenopausal

Clinical diagnosis of uterine myoma

Cervical liquid-based cytology and human papillomavirus typing test are negative

Disqualifiers

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

Trial population

The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) examined the uterine fibroid patients and healthy physical examination subjects.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Microscopic examination of vaginal discharge

    Diagnostic test

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: study group1 intervention
Group B: Healthy control group1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lin Yuan

Lead sponsor

Qianfoshan Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: