A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Cytokines Determination
研究概览
简要总结
The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.
详细描述
Our approach specifically targets the evaluation of the proteins and cytokines present and the bacteriological analysis of the microflora in the vaginal milieu.
Conjectures:
- An initial insult in the vagina (possibly involving a bacterial, viral or fungal organism or their products) causes modifications in the vaginal milieu
- The vaginal milieu responds to the insult by developing an inflammatory reaction characterized by cytokine and protein production
- Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing a reaction, chemical irritation or micro flora alteration by changes in proteins and/or abnormal protein production
- Those changes eventually result in hypersensitivity, irritation, burning, and pain manifested in patients with vulvodynia. And those changes may also result in the recurrence of fungal or bacterial infections
- Those changes may also contribute to initiate the cascade of premature events conducting to cervical effacement and dilation observed in preterm labor
The conjectures will be investigated by using a multidisciplinary approach including: microbiology, proteomics and cytokines evaluation of the vaginal milieu. Specifically we will be comparing an asymptomatic female population to serve as a baseline to patients affected by vulvodynia, recurrent fungal or bacterial vaginosis and/or pregnancy.
This is a prospective, descriptive study of about 550 women age 12 to 75 years. There will be four groups: 1) Asymptomatic healthy women, 2) Women being seen for any gynecological vulvovaginal condition, and 3) Pregnant women who are asymptomatic and healthy, and 4) Pregnant women have any gynecological vulvovaginal condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients willing to participate, and give informed consent, and
- •Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.
- •Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.
- •Pregnant women ages 21 to 75 years who are both asymptomatic and healthy
- •Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition
排除标准
- •Asymptomatic patients ages < 21 or > 75, or symptomatic patients ages < 21 or > 75 years.
- •Patients diagnosed with cancer or having any medical condition that is not under control including: diabetes mellitus, hypertension, collagen disease, hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic attacks
- •Patients unable to follow the protocol or unwilling to participate
结局指标
主要结局
Cytokines Determination
时间窗: one time for all except pregnant patients 4 times 12 months
To determine types of cytokines normally present in women's vagina and in patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor
次要结局
- Lactobacillus determination(one time for all except pregnant patients 4 times 12 months)
- Proteins Determination(one time for all except pregnant patients 4 times 12 months)