Diagnosis of Bacterial Vaginosis Comparing Modified Hay/I... | NCT04067557

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

NCT04067557

Sponsor

Skaraborg Hospital

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Infection, Bacterial

Interventions

molecuar test of BV

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2013Actual

Primary Completion Date

May 1, 2013Actual

Completion Date

Jun 1, 2013Actual

First Submitted Date

Aug 19, 2019

First Submission Date that Met QC Criteria

Aug 22, 2019

First Posted Date

Aug 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2019

Last Update Posted Date

Aug 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Actual

Name	Type	Description	Arm Group Labels	Other Names
molecuar test of BV	Diagnostic Test	diagnosis of BV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

women that are scheduled a therapeutic abortion screening visiting Skaraborg hospital Sweden

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
P-G Larsson	professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ob/Gyn, Skaraborgshospital Skövde		Skövde		541 85	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

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Browse Branches

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