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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067557
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Per-Goran Larsson, Skaraborg Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Infection, Bacterial Diagnostic Test: molecuar test of BV

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

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : May 1, 2013
Actual Study Completion Date : June 1, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases


Intervention Details:
  • Diagnostic Test: molecuar test of BV
    diagnosis of BV


Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
PCR diagnosis


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
women that are scheduled a therapeutic abortion screening visiting Skaraborg hospital Sweden
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067557


Locations
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Sweden
Department of Ob/Gyn, Skaraborgshospital Skövde
Skövde, Sweden, 541 85
Sponsors and Collaborators
Skaraborg Hospital
Investigators
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Principal Investigator: P-G Larsson professor
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Responsible Party: Per-Goran Larsson, professor, Skaraborg Hospital
ClinicalTrials.gov Identifier: NCT04067557    
Other Study ID Numbers: BV
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Bacterial Infections
Vaginal Diseases
Genital Diseases, Female
Vaginitis