Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04287504
Enrollment
400
Registered
2020-02-27
Start date
2020-02-14
Completion date
2021-07-31
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Bacterial, Infection, Fungal, Preterm Birth

Keywords

point-of-care test, validation, preterm birth, bacterial vaginosis, candidosis

Brief 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.

Interventions

DIAGNOSTIC_TESTSavvyCheck Vaginal Yeast Test

Point-of-care test for the detection of vaginal candidosis

DIAGNOSTIC_TESTOSOM BVBLUE Test

Point-of-care test for the detection of bacterial vaginosis

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Legal age (Participants must be 18 years or over) * Singleton pregnancy * No recent therapy with antibiotics within the last two weeks * No application of the following in the previous 72 hours before testing: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays

Exclusion criteria

* Age below 18 years * Multiple pregnancy * Recent treatment with antibiotics * Application of the following in the previous 72 hours: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays

Design outcomes

Primary

MeasureTime frameDescription
Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test10 minutesResult of point-of-care test

Secondary

MeasureTime frameDescription
Gestational age of deliveryapprox. 6 monthsTo assess preterm delivery rate

Countries

Austria

Contacts

Primary ContactPhilipp Foessleitner, MD BSc
philipp.foessleitner@meduniwien.ac.at+43140400
Backup ContactAlex Farr, MD PhD
alex.farr@meduniwien.ac.at+43140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026