NCT04287504

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

February 25, 2020

Last Update Submit

March 18, 2021

Conditions

Infection, BacterialInfection, FungalPreterm Birth

Keywords

point-of-care testvalidationpreterm birthbacterial vaginosiscandidosis

Outcome Measures

Primary Outcomes (1)

  • Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test

    Result of point-of-care test

    10 minutes

Secondary Outcomes (1)

  • Gestational age of delivery

    approx. 6 months

Study Arms (4)

Yeast, control

Women negative for vulvovaginal candidosis on Gram stain smear.

Diagnostic Test: SavvyCheck Vaginal Yeast Test

Yeast, study group

Women positive for vulvovaginal candidosis on Gram stain smear.

Diagnostic Test: SavvyCheck Vaginal Yeast Test

Bacterial vaginosis, control

Women negative for bacterial vaginosis on Gram stain smear.

Diagnostic Test: OSOM BVBLUE Test

Bacterial vaginosis, study group

Women positive for bacterial vaginosis on Gram stain smear.

Diagnostic Test: OSOM BVBLUE Test

Interventions

SavvyCheck Vaginal Yeast TestDIAGNOSTIC_TEST

Point-of-care test for the detection of vaginal candidosis

Yeast, controlYeast, study group
OSOM BVBLUE TestDIAGNOSTIC_TEST

Point-of-care test for the detection of bacterial vaginosis

Bacterial vaginosis, controlBacterial vaginosis, study group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Dept. of Obstetrics and Gynecology

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Bacterial InfectionsMycosesPremature BirthVaginosis, BacterialCandidiasis

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Diseases

Study Officials

  • Herbert Kiss, MD MBA

    Medical University of Vienna

    STUDY DIRECTOR

Central Study Contacts

Philipp Foessleitner, MD BSc

CONTACT

+43140400philipp.foessleitner@meduniwien.ac.at

Alex Farr, MD PhD

CONTACT

+43140400alex.farr@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Consultant Physician

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

February 14, 2020

Primary Completion

March 18, 2021

Study Completion

July 31, 2021

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

on request

Locations

AU(1)