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Point-of-care Tests for Bacterial Vaginosis and Candidosis

NCT04287504 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2021-03-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Herbert Kiss, MD MBA · Medical University of Vienna

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2021-03-18
Completion
2021-07-31
FDA Device
Yes

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04287504 on ClinicalTrials.gov