NCT01496898已完成不适用
Vaginal Microflora and Inflammatory Markers Before and After Levonorgestrel Device Insertion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement
研究概览
简要总结
The goal of this study is to examine changes in the bacterial ecology and inflammatory markers of the female genital tract with levonorgestrel intrauterine device placement.
The specific research objectives of this project include:
- Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis. Samples will be collected up to 1 week before and 2 months after IUD insertion.
- Characterization of vaginal, cervical and uterine inflammatory cytokine milieu prior to and after LNG IUD placement using human RNA microarray analysis. Samples will be analyzed from up to one day before and three weeks after IUD insertion.
- Establish a tissue bank of vaginal, cervical and uterine specimens for future research.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Not currently pregnant
- •No use of hormonal birth control for at least three months prior to enrollment
- •Desiring levonorgestrel IUD for birth control
- •Greater than 6 months postpartum
- •Greater than 6 weeks after miscarriage
- •No antibiotic use in the past 6 weeks
排除标准
- •Uterine Abnormalities
- •Current use of hormonal contraceptives or use less than 3 months ago
- •Unexplained vaginal bleeding
- •Irregular menses
- •Cervical dysplasia
- •Cervical or vaginal infection in the last 6 weeks
- •Douching within the week prior to sample collection
- •Use of vaginal lubricants within the week prior to sample collection
结局指标
主要结局
Changes in vaginal, cervical and uterine bacterial species with levonorgestrel intrauterine device placement
时间窗: 1 week prior to IUD insertion to 2 months after IUD insertion
Characterization of vaginal, cervical and uterine bacterial species and communities prior to and after LNG IUD placement using bacterial DNA microarray analysis
次要结局
- Inflammatory cytokine changes with levonorgestrel intrauterine device placement(1 day prior to IUD insertion to 3 weeks after IUD insertion)
研究者
研究点 (1)
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