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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04287504
Other study ID # 2115-2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 14, 2020
Est. completion date July 31, 2021

Study information

Verified date March 2021
Source Medical University of Vienna
Contact Philipp Foessleitner, MD BSc
Phone +43140400
Email philipp.foessleitner@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date July 31, 2021
Est. primary completion date March 18, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
SavvyCheck Vaginal Yeast Test
Point-of-care test for the detection of vaginal candidosis
OSOM BVBLUE Test
Point-of-care test for the detection of bacterial vaginosis

Locations

Country Name City State
Austria Medical University of Vienna, Dept. of Obstetrics and Gynecology Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test Result of point-of-care test 10 minutes
Secondary Gestational age of delivery To assess preterm delivery rate approx. 6 months
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