Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,590
- 主要终点
- Relative Abundance
研究概览
简要总结
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.
详细描述
This study consists of two sub-studies:
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
- •exclusion Criteria:
- •Receiving systemic or vaginal antifungal or antibiotic treatment within the past week.
排除标准
- 未提供
结局指标
主要结局
Relative Abundance
时间窗: May 2024
Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis.
The score for smear
时间窗: December 2023
This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear.
Diagnosis of vaginitis type
时间窗: March 2024
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.
Intensity
时间窗: May 2024
The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis.
次要结局
未报告次要终点
研究者
Fengxia Xue
Director of the Medical Center for Obstetrics and Gynecology
Tianjin Medical University General Hospital