Point-of-care Tests for Bacterial Vaginosis and Candidosis

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT04287504

Collaborator

(none)

400

Enrollment

Location

17.5

Anticipated Duration (Months)

22.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection, Bacterial Infection, Fungal Preterm Birth	Diagnostic Test: SavvyCheck Vaginal Yeast Test Diagnostic Test: OSOM BVBLUE Test

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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 14, 2020

Actual Primary Completion Date :

Mar 18, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test [10 minutes]
Result of point-of-care test

Secondary Outcome Measures

Gestational age of delivery [approx. 6 months]
To assess preterm delivery rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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