Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group
研究概览
简要总结
The study participants are patients with uterine fibroids and healthy physical examination subjects from the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital). The main purpose of this study is to analyze the correlation between uterine fibroids and vaginal microecology and cervical local immune function in patients of childbearing age.
详细描述
(1) In this study, 150 women of childbearing age who are diagnosed with uterine fibroids in the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital) are selected as the study group; The differences of vaginal microenvironment and cervical local immune function are compared between 150 healthy women of childbearing age in the same period. (2) After the patients are enrolled, the general information (age, height, weight), menstrual status (age of menarche, menstrual period, cycle, bleeding pattern), clinical manifestations (abnormal uterine bleeding, infertility, abdominal pain), and previous medical history (hypertension, thyroid disease, etc.) of 150 patients with uterine fibroids will be collected. After the end of the first part of the experiment, 150 patients with uterine fibroids will be grouped according to vaginal microecological diagnosis, and the clinical characteristics of patients with uterine fibroids will be analyzed and compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Study group inclusion criteria:
- •Age 20-49 years old
- •Premenopausal
- •Clinical diagnosis of uterine myoma
- •Cervical liquid-based cytology and human papillomavirus typing test are negative
- •Healthy control group:
- •Age 20-49 years old
- •Premenopausal
- •Uterine B-ultrasonography is normal
- •Cervical liquid-based cytology and human papillomavirus typing test are negative
- •No vaginal infection
排除标准
- •Exclusion criteria of the study group:
- •Used antibiotics, hormones, immunosuppressants and regulators within 1 month
- •Sex, vaginal irrigation or applied medicine 3 days before the vaginal discharge sampling
- •Pregnant, lactating or menstruating women
- •Uterus and uterine adnexa have other lesions
- •Exclusion criteria of healthy control group:
- •Used antibiotics, hormones, immunosuppressants and regulators within 1 month
- •Sex, vaginal irrigation or applied medicine 3 days before the vaginal discharge sampling
- •Pregnant, lactating or menstruating women
结局指标
主要结局
Bacterial vaginitis (BV) of vaginal microecosystem-150 people in each group
时间窗: through study completion, an average of 2.5 year
Nugent score is currently an internationally accepted diagnostic method for BV. Lactobacillus, Gardnerella vaginalis, bacterioid bacteria and campylobacter with variable staining are evaluated by Gram staining and semi-quantitative evaluation method. The total score is the sum of the scores of the above 4 bacteria. 0 to 3 points: normal; 4 \~ 6 points: intermediate BV; ≥7 points: BV
次要结局
未报告次要终点
研究者
Lin Yuan
technologist in charge
Qianfoshan Hospital