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

Completed

• Conditions: Infection, Bacterial

• Registration Number: NCT04067557
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2013-05-01
• Study Completion: 2013-06-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-23
• Study First Posted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Ob/Gyn, Skaraborgshospital Skövde; 🇸🇪 Skövde, Sweden