Clinical trial NCT04287504: Point-of-care Tests for Bacterial Vaginosis and Candidosis
Official title: Validation of the OSOM BVBLUE Test for Bacterial Vaginosis and the SavvyCheck Vaginal Yeast Test for Vaginal Candidosis: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection, Bacterial
Infection, Fungal
Preterm Birth
Keywords: point-of-care test
validation
preterm birth
bacterial vaginosis
candidosis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitement will take place during routine birth registration at the obstetric outpatient clinic at the Department of Obstetrics and Gynecology at the Medical University of Vienna. All data will be collected anonymized and encoded with numbers. Pregnant women will be screened for asymptomatic and symptomatic vaginal infection via Gram stain as part of routine management. Vaginal smears will be assessed by sterile swabs from the lateral vaginal wall and posterior fornix vaginae. Two swabs will be collected. The second swab will be taken for study purposes to undergo the OSOM BVBLUE Test for bacterial vaginosis or the SavvyCheck Vaginal Yeast Test for vaginal candidosis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test
timeFrame: 10 minutes
Secondary outcomes:
measure: Gestational age of delivery
timeFrame: approx. 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Dept. of Obstetrics and Gynecology
Study officials:
affiliation: Medical University of Vienna
name: Herbert Kiss, MD MBA
role: STUDY_DIRECTOR
References: