Infection, BacterialNCT04067557
Diagnosis of Bacterial Vaginosis Comparing Modified Hay/Ison With Molecular Diagnosis
An observational study of Infection, Bacterial, run by Skaraborg Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- molecuar test of BV
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2013to 1 Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: women that are scheduled a therapeutic abortion screening visiting Skaraborg hospital Sweden
Who may be able to join
- women scheduled a therapeutic abortion (Before 12th week) will be screened for gential infections such as chlamydia and Gc together with bacterial vaginosis
Who cannot join
- women not pregnat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.
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.
Read the detailed description
The molecular test will test for Atophobium vaginae, Leopitrichia spp, Megasphaera Mobiluncus and BVAB2
- Conditions
- Infection, Bacterial
- Being tested
- molecuar test of BV
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
molecuar test of BVDiagnostic test
diagnosis of BV
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Jan 2013
- Primary completion1 May 2013
- Study completion1 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skaraborg Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Per-Goran Larsson, Skaraborg Hospital
- Investigators
- P-G Larsson, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067557
- Sponsor's protocol ID
- BV
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Bacterial Vaginosis Using Molecular PCR Test.
- ClinicalTrials.gov ID
- NCT04067557
- Acronym / sponsor ID
- BV
- Conditions
- Infection, Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Skaraborg HospitalOther government
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 Jun 2013 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- women that are scheduled a therapeutic abortion screening visiting Skaraborg hospital Sweden
Key inclusion criteria (1 listed)
- women scheduled a therapeutic abortion (Before 12th week) will be screened for gential infections such as chlamydia and Gc together with bacterial vaginosis
Key exclusion criteria (1 listed)
- women not pregnat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| molecuar test of BVdiagnosis of BV | Diagnostic test | – |
Primary outcome
Diagnosis of bacterial vaginosis comparing modified Hay/Ison with molecular diagnosis
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P-G Larsson principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Bacterial, run by Skaraborg Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of bacterial vaginosis comparing modified Hay/Ison with molecular diagnosis (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.