NCT04287504

Point-of-care Tests for Bacterial Vaginosis and Candidosis

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Infection, Bacterial
• Infection, Fungal
• Preterm Birth

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SavvyCheck Vaginal Yeast Test	Point-of-care test for the detection of vaginal candidosis
DIAGNOSTIC_TEST	OSOM BVBLUE Test	Point-of-care test for the detection of bacterial vaginosis

Timeline

• Start date: 2020-02-14
• Primary completion: 2021-03-18
• Completion: 2021-07-31
• First posted: 2020-02-27
• Last updated: 2021-03-19

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study