Point-of-care Tests for Bacterial Vaginosis and Candidosis

• Conditions: Preterm Birth; Infection, Fungal; Infection, Bacterial
• Interventions: Diagnostic Test: SavvyCheck Vaginal Yeast Test; Diagnostic Test: OSOM BVBLUE Test

• Registration Number: NCT04287504
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2020-02-14
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Status Verified: 2021-03
• Primary Completion: 2021-03-18
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Yeast, control	SavvyCheck Vaginal Yeast Test	Women negative for vulvovaginal candidosis on Gram stain smear.
Yeast, study group	SavvyCheck Vaginal Yeast Test	Women positive for vulvovaginal candidosis on Gram stain smear.
Bacterial vaginosis, control	OSOM BVBLUE Test	Women negative for bacterial vaginosis on Gram stain smear.
Bacterial vaginosis, study group	OSOM BVBLUE Test	Women positive for bacterial vaginosis on Gram stain smear.

Primary Outcome Measures

Name	Time	Method
Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test	10 minutes	Result of point-of-care test

Secondary Outcome Measures

Name	Time	Method
Gestational age of delivery	approx. 6 months	To assess preterm delivery rate

Trial Locations

Locations (1)

Medical University of Vienna, Dept. of Obstetrics and Gynecology; 🇦🇹 Vienna, Austria