Morphological Detection of Liquid-based Thin-layer Film-making Fungi for Fungal Vaginitis in Multiple Hospitals

Affiliated Hospital of Nantong University

Status: Unknown

Conditions: Vaginitis

Treatments: Diagnostic Test: Fluorescence morphological detection of liquid-based thin-layer film-making fungi

Study type: Observational

Funder types: Other

Identifiers

NCT04984460

AHNantongU_YEZH_NTFS_V1.0

Details and patient eligibility

About

The purpose of this study is to compare the results of different detection methods for non-gestational fungal vaginitis (VVC), and to evaluate the significance of different fungal states in the results for diagnosis and treatment.

Full description

The study was divided into two phases: in the first phase, the vaginal secretions of 1000 enrolled patients with fungal vaginitis were detected with 3/4 different methods, and the sensitivity, specificity and consistency of these methods were compared; In the second stage, 1000 patients from the first stage were selected to meet the follow-up stage and divided into two groups. The test of Follow-up fungal culture and fluorescence morphological detection of liquid-based thin-layer film-making fungi were performed periodically. At last, the applicant will analyze the data, write the paper and publish the article.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Samples from outpatient or inpatient clinics to be tested for fungal vaginitis.
• 2. A sample of one or more of the following characteristics. 2.1 Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased.

2.2 Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.

• 3. The samples are vaginal secretions from the female body. Each sample should be the amount on one swab.
• 4. The sample is not in menstrual period.
• 5. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days.

Exclusion criteria

• 1. Cases with incomplete specimen collection;
• 2. Mixed vaginitis cases;
• 3. Abscission cases with incomplete follow-up.

Trial design

1,000 participants in 1 patient group

life-style counseling

Description:

A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased. Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.

Treatment:

Diagnostic Test: Fluorescence morphological detection of liquid-based thin-layer film-making fungi