NCT04984460

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

July 22, 2021

Last Update Submit

July 22, 2021

Conditions

Vaginitis

Keywords

Fluorescence morphologicalliquid-based thin-layer film-makingFungal vaginitis

Outcome Measures

Primary Outcomes (3)

  • Comparing the positive detection rate of 3/4 different detection methods in the first phase.

    The positive coincidence rate (sensitivity), negative coincidence rate (specificity) and total coincidence rate (consistency) was compared, according to the P\<0.05 was used to determine whether it was statistically significant.

    From Aug. 1st to Dec. 31st, 2021

  • Calculating the proportion of the number of fungi in three different states in the map results of three/four detection methods.

    Counting The number and proportion of mycelia, spores and blastospores, especially the percentage of cases of single spore (+) in all cases of fungus (+).

    From Aug. 1st, 2021 to Jan. 31st, 2022

  • Counting the positive numbers of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests and fungal culture in the Stage 2_follow-up stage.

    the positive coincidence rate (sensitivity), negative coincidence rate (specificity) of 4 or 6 liquid-based thin-layer fungal fluorescence morphological tests

    From Mar. 1, 2022 to Dec. 31st, 2022

Study Arms (1)

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.

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

Interventions

Fluorescence morphological detection of liquid-based thin-layer film-making fungiDIAGNOSTIC_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.

life-style counseling

Eligibility Criteria

Age14 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFungal vaginitis is a disease that only women get.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients with suspected fungal vaginitis.

You may qualify if:

  • \. Samples from outpatient or inpatient clinics to be tested for fungal vaginitis.
  • \. 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.
  • 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.
  • \. The samples are vaginal secretions from the female body. 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.

You may not qualify if:

  • \. Cases with incomplete specimen collection;
  • \. Mixed vaginitis cases;
  • \. Abscission cases with incomplete follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

The First Affiliated Hospital of Ustc

Hefei, Anhui, 230031, China

Location

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

Location

The Second Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226006, China

Location

Affiliated Nantong Hospital Of Shanghai University

Nantong, Jiangsu, China

Location

Nantong Maternal and Child Health Hospital

Nantong, Jiangsu, China

Location

Children's Hospital of Fudan University Qidong Branch

Qidong, Jiangsu, China

Location

Jiujiang Maternal and Child Health Hospital

Jiujiang, Jiangxi, China

Location

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, 330006, China

Location

Changning District Maternal and Child Health Care Hospital

Shanghai, Shanghai Municipality, 200051, China

Location

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Yuquan Zhang, Doctor

    Affiliated Hospital of Nantong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Obstetrics and Gynaecology

Study Record Dates

First Submitted

July 22, 2021

First Posted

July 30, 2021

Study Start

July 9, 2021

Primary Completion

December 31, 2022

Study Completion

April 1, 2023

Last Updated

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Not planning sharing at present.

Locations

CN(10)