Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining
VENUS
1 other identifier
observational
5,590
0 countries
N/A
Brief Summary
The goal of this observational study is to explore a standardized sample process for improving the accuracy of vaginal microbiota evaluation and to explore a more complete and comprehensive method for vaginal microbiota evaluation based on gram staining.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedAugust 18, 2023
August 1, 2023
1.8 years
August 10, 2023
August 10, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
The score for smear
This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear.
December 2023
Diagnosis of vaginitis type
The Diagnosis of vaginitis type based on Gram-stained smear and antigen testing, including aerobic vaginitis(AV), bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), and normal.
March 2024
Relative Abundance
Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis.
May 2024
Intensity
The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis.
May 2024
Study Arms (1)
hospital name + infection type + number
There is no intervention.
Eligibility Criteria
VENUS study plans to enrol 5590 participants, aged 15-49 years, from visiting our research settings across the country who evaluate vaginal discharge based on Gram-stained smear.
You may qualify if:
- Non-pregnant women who visit our research settings and conduct vaginal discharge examination based on Gram-stained smear.
- No sexual intercourse, vaginal douching, or vaginal medication within the last 72 hours.
- Not during menstruation (menstrual period ended ≥3 days ago).
You may not qualify if:
- Receiving systemic or vaginal antifungal or antibiotic treatment within the past week.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengxia Xue, PhD
Tianjin Medical University General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Medical Center for Obstetrics and Gynecology
Study Record Dates
First Submitted
August 10, 2023
First Posted
August 18, 2023
Study Start
September 1, 2023
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
August 18, 2023
Record last verified: 2023-08