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NCT04415840 Clinical Trial

Lugol's Solution in Addition to Acetic Acid During Colposcopy

Uterine Cervical Dysplasia Clinical Trial

Official title:
Benefits of Using Lugol's Solution in Addition to Acetic Acid During Colposcopy in Women With Cervical Dysplasia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04415840
Other study ID # COLPO-4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 31, 2020
Est. completion date July 1, 2021

Study information
Verified date April 2021
Source Zydolab - Institute of Cytology and Immune Cytochemistry
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess the benefits of using Lugol's solution in addition to acetic acid during colposcopy in women with cervical dysplasia.

Recruitment information / eligibility
Status Completed
Enrollment 323
Est. completion date July 1, 2021
Est. primary completion date May 25, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - women referred for colposcopy due to cervical abnormalities - written informed consent Exclusion Criteria: - pregnant women - presence of a language barrier - history of conization or other treatments on the cervix uteri - iodine allergy

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• acetic acid test
using acetic acid to unmask dysplastic lesions on the cervix uteri
• Lugol's solution test
using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri

Locations
Country Name City State
Germany Zydolab - Institute of Cytology and Immune Cytochemistry Dortmund NRW
Germany Department of Obstetrics and Gynecology of the Ruhr University Bochum Herne NRW

Sponsors (1)
Lead Sponsor Collaborator
Zydolab - Institute of Cytology and Immune Cytochemistry

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use 1 minute
Secondary Sensitivity sensitivity of the examination (acetic acid + Lugol´s solution) 1 minute
Secondary Specificity Specificity of the examination (acetic acid + Lugol´s solution) 1 minute
Secondary PPV Positive predictive value of the examination (acetic acid + Lugol´s solution) 1 minute
Secondary NPV Negative predictive value of the examination (acetic acid + Lugol´s solution) 1 minute
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