Status:

UNKNOWN

Point-of-care Tests for Bacterial Vaginosis and Candidosis

Lead Sponsor:

Medical University of Vienna

Conditions:

Infection, Bacterial

Infection, Fungal

Eligibility:

FEMALE

18-45 years

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 4...

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 d...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 14 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    July 31 2021

    Estimated Enrollment :

    400 Patients enrolled

    Trial Details

    Trial ID

    NCT04287504

    Start Date

    February 14 2020

    End Date

    July 31 2021

    Last Update

    March 19 2021

    Active Locations (1)

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    1

    Medical University of Vienna, Dept. of Obstetrics and Gynecology

    Vienna, Austria, 1090