Point-of-care Tests for Bacterial Vaginosis and Candidosis

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04287504
• Other study ID #: 2115-2019
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bacterial Infections
• Candidiasis
• Communicable Diseases
• Infection
• Infection, Bacterial
• Infection, Fungal
• Mycoses
• Premature Birth
• Preterm Birth
• Vaginal Diseases
• Vaginosis, Bacterial

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