Point-of-care Tests for Bacterial Vaginosis and Candidosis

March 18, 2021 updated by: Alex Farr, MD PhD, Medical University of Vienna

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna, Dept. of Obstetrics and Gynecology
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Herbert Kiss, MD MBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Recruitement will take place during routine birth registration at the obstetric outpatient clinic at the Department of Obstetrics and Gynecology at the Medical University of Vienna. All data will be collected anonymized and encoded with numbers. Pregnant women will be screened for asymptomatic and symptomatic vaginal infection via Gram stain as part of routine management. Vaginal smears will be assessed by sterile swabs from the lateral vaginal wall and posterior fornix vaginae. Two swabs will be collected. The second swab will be taken for study purposes to undergo the OSOM BVBLUE Test for bacterial vaginosis or the SavvyCheck Vaginal Yeast Test for vaginal candidosis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Yeast, control
Women negative for vulvovaginal candidosis on Gram stain smear.
Diagnostic test: SavvyCheck Vaginal Yeast Test
Point-of-care test for the detection of vaginal candidosis
Yeast, study group
Women positive for vulvovaginal candidosis on Gram stain smear.
Diagnostic test: SavvyCheck Vaginal Yeast Test
Point-of-care test for the detection of vaginal candidosis
Bacterial vaginosis, control
Women negative for bacterial vaginosis on Gram stain smear.
Diagnostic test: OSOM BVBLUE Test
Point-of-care test for the detection of bacterial vaginosis
Bacterial vaginosis, study group
Women positive for bacterial vaginosis on Gram stain smear.
Diagnostic test: OSOM BVBLUE Test
Point-of-care test for the detection of bacterial vaginosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test
Time Frame: 10 minutes
Result of point-of-care test
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational age of delivery
Time Frame: approx. 6 months
To assess preterm delivery rate
approx. 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Study Director: Herbert Kiss, MD MBA, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2020

Primary Completion (Actual)

March 18, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2115-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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