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Point-of-care Tests for Bacterial Vaginosis and Candidosis

Preterm Birth Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04287504
Study type Observational
Source Medical University of Vienna
Contact Philipp Foessleitner, MD BSc
Phone +43140400
Email philipp.foessleitner@meduniwien.ac.at
Status Recruiting
Phase
Start date February 14, 2020
Completion date July 31, 2021
View Details
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