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

Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04067557

Enrollment

300

Registered

2019-08-26

Start date

2013-01-01

Completion date

2013-06-01

Last updated

2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Bacterial

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.

Detailed description

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

Interventions

DIAGNOSTIC_TESTmolecuar test of BV

diagnosis of BV

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnosis of bacterial vaginosis comparing modified Hay/Ison with molecular diagnosis	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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026