Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnosis of bacterial vaginosis comparing modified Hay/Ison with molecular diagnosis
研究概览
简要总结
Among 300 women that are scheduled a therapeutic abortion screening diagnopsis of BV are done using Gram stained vaginal smear and with a molecular test using PCR for 5 different bacteria.
详细描述
The molecular test will test for Atophobium vaginae, Leopitrichia spp, Megasphaera Mobiluncus and BVAB2
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •women scheduled a therapeutic abortion (Before 12th week) will be screened for gential infections such as chlamydia and Gc together with bacterial vaginosis
排除标准
- •women not pregnat
结局指标
主要结局
Diagnosis of bacterial vaginosis comparing modified Hay/Ison with molecular diagnosis
时间窗: 4 month
Comparing the Gram stained vaginal smears using Hay/Ison (i.e. BV or normal) criteria with a molecular PCR method with 5 different bacterium and after an algoritm end up with the result (i.e. BV or normal). The number of women with the diagnosis of BV with each of the diagnostic test can be compared calculatitng a KAPPA index
次要结局
未报告次要终点
研究者
Per-Goran Larsson
professor
Skaraborg Hospital