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OpenTrials
Completed

NCT Number: NCT04067557

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

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.

Completed

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Key information

Study type

Observational

Primary location

Department of Ob/Gyn, Skaraborgshospital Skövde

Skövde, 541 85, Sweden

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

molecuar test of BV

Diagnostic Test

diagnosis of BV

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Skaraborg Hospital

Other Gov

Registry information

Official study title

Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 26, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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