NCT04067557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

August 19, 2019

Last Update Submit

August 23, 2019

Conditions

Infection, Bacterial

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

molecuar test of BVDIAGNOSTIC_TEST

diagnosis of BV

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • women scheduled a therapeutic abortion (Before 12th week) will be screened for gential infections such as chlamydia and Gc together with bacterial vaginosis

You may not qualify if:

  • women not pregnat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ob/Gyn, Skaraborgshospital Skövde

Skövde, 541 85, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

PCR diagnosis

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • P-G Larsson

    professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 26, 2019

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

SE(1)