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

Infection, Bacterial Clinical Trial

Official title:

Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067557
• Other study ID #: BV
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: June 1, 2013

Study information

• Verified date: August 2019
• Source: Skaraborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 1, 2013
• Est. primary completion date: May 1, 2013
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial
• Vaginosis, Bacterial

Intervention

Diagnostic Test:
• molecuar test of BV
diagnosis of BV

Locations

Country	Name	City	State
Sweden	Department of Ob/Gyn, Skaraborgshospital Skövde	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
Skaraborg Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 month