Point-of-care Tests for Bacterial Vaginosis and Candidosis

Medical University of Vienna

Status: Unknown

Conditions: Infection, Fungal; Infection, Bacterial; Preterm Birth

Treatments: Diagnostic Test: SavvyCheck Vaginal Yeast Test; Diagnostic Test: OSOM BVBLUE Test

Study type: Observational

Funder types: Other

Identifiers

NCT04287504

2115-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 4 patient groups

Yeast, control

Description:

Women negative for vulvovaginal candidosis on Gram stain smear.

Treatment:

Diagnostic Test: SavvyCheck Vaginal Yeast Test

Yeast, study group

Description:

Women positive for vulvovaginal candidosis on Gram stain smear.

Treatment:

Diagnostic Test: SavvyCheck Vaginal Yeast Test

Bacterial vaginosis, control

Description:

Women negative for bacterial vaginosis on Gram stain smear.

Treatment:

Diagnostic Test: OSOM BVBLUE Test

Bacterial vaginosis, study group

Description:

Women positive for bacterial vaginosis on Gram stain smear.

Treatment:

Diagnostic Test: OSOM BVBLUE Test