Point-of-care Tests for Bacterial Vaginosis and Candidosis

Study Overview
=================
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.

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

Conditions
-----------------
Infection, Bacterial, Infection, Fungal, Preterm Birth

Intervention / Treatment
-----------------
* Diagnostic Test: SavvyCheck Vaginal Yeast Test
* Diagnostic Test: OSOM BVBLUE Test


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Yeast, control<br>Women negative for vulvovaginal candidosis on Gram stain smear. | Diagnostic Test: SavvyCheck Vaginal Yeast Test<br>* Point-of-care test for the detection of vaginal candidosis<br>|
| Yeast, study group<br>Women positive for vulvovaginal candidosis on Gram stain smear. | Diagnostic Test: SavvyCheck Vaginal Yeast Test<br>* Point-of-care test for the detection of vaginal candidosis<br>|
| Bacterial vaginosis, control<br>Women negative for bacterial vaginosis on Gram stain smear. | Diagnostic Test: OSOM BVBLUE Test<br>* Point-of-care test for the detection of bacterial vaginosis<br>|
| Bacterial vaginosis, study group<br>Women positive for bacterial vaginosis on Gram stain smear. | Diagnostic Test: OSOM BVBLUE Test<br>* Point-of-care test for the detection of bacterial vaginosis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test | Result of point-of-care test | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age of delivery | To assess preterm delivery rate | approx. 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
point-of-care test, validation, preterm birth, bacterial vaginosis, candidosis