Diagnosis of Bacterial Vaginosis Comparing Modified Hay/Ison With Molecular Diagnosis

August 23, 2019 updated by: Per-Goran Larsson, Skaraborg Hospital

Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.

Among 300 women that are scheduled a therapeutic abortion screening diagnopsis of BV are done using Gram stained vaginal smear and with a molecular test using PCR for 5 different bacteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The molecular test will test for Atophobium vaginae, Leopitrichia spp, Megasphaera Mobiluncus and BVAB2

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Skövde, Sweden, 541 85
        • Department of Ob/Gyn, Skaraborgshospital Skövde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

women that are scheduled a therapeutic abortion screening visiting Skaraborg hospital Sweden

Description

Inclusion Criteria:

women scheduled a therapeutic abortion (Before 12th week) will be screened for gential infections such as chlamydia and Gc together with bacterial vaginosis

Exclusion Criteria:

  • women not pregnat

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of bacterial vaginosis comparing modified Hay/Ison with molecular diagnosis
Time Frame: 4 month
Comparing the Gram stained vaginal smears using Hay/Ison (i.e. BV or normal) criteria with a molecular PCR method with 5 different bacterium and after an algoritm end up with the result (i.e. BV or normal). The number of women with the diagnosis of BV with each of the diagnostic test can be compared calculatitng a KAPPA index
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skaraborg Hospital

Investigators

  • Principal Investigator: P-G Larsson, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (ACTUAL)

August 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 23, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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