Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining

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

5590 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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This study consists of two sub-studies:

1. Sub-study on Standardized method of Microscopic Slide Preparation: this sub-study aims to compare different slide preparation methods and dilution levels based on various aspects, including uniformity, impurities, clarity and so on, and then explore the optimal method and dilution level. Additionally, it will summarize the conversion method for white blood cells between wet mount and gram staining, and for white blood cells between high-power microscopy and oil immersion microscopy.
2. Sub-study on Vaginal Microbiota Evaluation on Gram Staining: For patients with diagnosed vaginal infection type, it will calculate the consistency of results between different laboratories. And it will evaluate the effectiveness combined artificial intelligence technology and other technological platforms. Besides, for patients without diagnosed vaginal infection type, different methods such as 16S rRNA gene sequencing and metagenomic sequencing are used for analysis and profiling to guide treatment.

Conditions

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Vaginal Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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hospital name + infection type + number

There is no intervention.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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).