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

NCT ID: NCT04984460

Last Updated: 2021-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-09

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vaginitis

Keywords

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Fluorescence morphological liquid-based thin-layer film-making Fungal vaginitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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life-style counseling

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.

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

Intervention Type DIAGNOSTIC_TEST

Samples from outpatient or inpatient clinics to be tested for fungal vaginitis. 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.

Samples are human vaginal secretions. Each sample should be the amount on one swab.

The sample is not in menstrual period. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days.

Interventions

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

Samples from outpatient or inpatient clinics to be tested for fungal vaginitis. 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.

Samples are human vaginal secretions. Each sample should be the amount on one swab.

The sample is not in menstrual period. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Yuquan Zhang

Director of Obstetrics and Gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuquan Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Nantong University

Locations

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The First Affiliated Hospital of Ustc

Hefei, Anhui, China

Site Status

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

Site Status

The Second Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status

Affiliated Nantong Hospital Of Shanghai University

Nantong, Jiangsu, China

Site Status

Nantong Maternal and Child Health Hospital

Nantong, Jiangsu, China

Site Status

Children's Hospital of Fudan University Qidong Branch

Qidong, Jiangsu, China

Site Status

Jiujiang Maternal and Child Health Hospital

Jiujiang, Jiangxi, China

Site Status

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Site Status

Changning District Maternal and Child Health Care Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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AHNantongU_YEZH_NTFS_V1.0

Identifier Type: -

Identifier Source: org_study_id