Clinical Trials

 

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

Intervention Type: Diagnostic Test
Study Type: Observational
Sponsors: Medical University of Vienna
Participants: 400
Abstract
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.
* Consult with your doctor before enrolling in clinical trials.
Facilities
Medical University of Vienna, Dept. of Obstetrics and Gynecology - Recruiting
Vienna, Austria
Contacts
Backup
Alex Farr, MD PhD
alex.farr@meduniwien.ac.at
+43140400 ext 28220
Primary
Philipp Foessleitner, MD BSc
philipp.foessleitner@meduniwien.ac.at
+43140400 ext 28220
Eligibilities
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy 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

View Article From Source