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

Skaraborg Hospital300 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Infection, Bacterial

Interventions

molecuar test of BVDIAGNOSTIC_TEST

diagnosis of BV

Eligibility

Medical Language ↔ Plain English

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

Locations (1)

Department of Ob/Gyn, Skaraborgshospital Skövde

Skövde, Sweden

Outcomes

Primary Outcomes

Diagnosis of bacterial vaginosis comparing modified Hay/Ison with molecular diagnosis

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

Time frame: 4 month

Data from ClinicalTrials.gov

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