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临床试验/NCT04287504
NCT04287504Unknown不适用

Validation of the OSOM BVBLUE Test for Bacterial Vaginosis and the SavvyCheck Vaginal Yeast Test for Vaginal Candidosis: A Prospective Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年2月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test

研究概览

简要总结

Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are Gardnerella vaginalis, Candida albicans and Trichomonas vaginalis. The aim of this prospective study is the validation of the point-of-care tests OSOM BVBLUE for bacterial vaginosis and SavvyCheck Vaginal Yeast Test for candidosis in comparison to Gram stain.

详细描述

In the present study, it should be examined whether the OSOM BVBLUE for bacterial vaginosis and the SavvyCheck Vaginal Yeast Test for vaginal candidosis are superior, equal/comparable or inferior to diagnosis on Gram stained smears. The point-of-care-tests are potential tools for the adequate diagnosis of bacterial vaginosis and vaginal candidosis in early pregnancy, since the prevention of these infections, as well as the infection screening per se, have the potential to prevent preterm birth and reduce the rate of late abortion. Point-of-care-tests are easy to perform, relatively cheap, and widely available. Routine implementation of the tests would be an effective contribution to the reduction of preterm labor and late-onset mortality.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test

时间窗: 10 minutes

Result of point-of-care test

次要结局

  • Gestational age of delivery(approx. 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Farr, MD PhD

Assistant Professor, Consultant Physician

Medical University of Vienna

研究点 (1)

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