Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections : A Large, Cross-sectional, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,028
- 试验地点
- 2
- 主要终点
- Bacterial infection detection rates
研究概览
简要总结
Screening for genital infection (GI), sexually transmitted infection (STI) and asymptomatic carriage of group B streptococcus (GBS) in pregnant women is a common reason for medical appointments. Conventional testing is performed by using vaginal and/or cervical classic sampling (VCS). Vaginal self-sampling (VSS) has progressively emerged as an alternative to VCS for STI agent screening. The use of vaginal self-sampling (VSS) could facilitate follow-ups and potentially help in the prevention of gynaecological disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women requiring vaginal or cervical classical sampling to screen for genital infections
- •Women requiring vaginal or cervical classical sampling to screen for sexually transmitted infections (STI)
- •Pregnant women requiring vaginal classical sampling to screeen for Group B streptococcus asymptomatic carriage in the eighth month of pregnancy
- •Informed written consent from the patient
排除标准
- •Person subjected to therapeutic limitation decision
- •Women with intact hymen
- •Active antibiotic or antifungic treatment
- •Antiobiotic or antifungic treatment during the 10 days prior to inclusion
研究组 & 干预措施
Genital infections
Women with vaginal/cervical sampling indications
干预措施: Vaginal self-sampling (Procedure)
结局指标
主要结局
Bacterial infection detection rates
时间窗: 10 days
Bacterial infection detection rates of VSS compared with VCS
Yeast infection detection rates
时间窗: 10 days
Yeast infection detection rates of VSS compared with VCS
Chlamydia trachomatis detection rates
时间窗: 10 days
Chlamydia trachomatis detection rates of VSS compared with VCS
Neisseria gonorrhoeae detection rates
时间窗: 10 days
Neisseria gonorrhoeae detection rates of VSS compared with VCS
Mycoplasma genitalium detection rates
时间窗: 10 days
Mycoplasma genitalium detection rates of VSS compared with VCS
Trichomonas vaginalis detection rates
时间窗: 10 days
Trichomonas vaginalis detection rates of VSS compared with VCS
Human simplex virus detection rates
时间窗: 10 days
Human simplex virus detection rates of VSS compared with VCS
Group B streptococcus detection rates
时间窗: 10 days
Group B streptococcus detection rates of VSS compared with VCS
次要结局
未报告次要终点
研究者
Edwin QUARELLO @me.com
Principal investigator
Hôpital Européen Marseille