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Completed

NCT Number: NCT04415840

Lugol's Solution in Addition to Acetic Acid During Colposcopy

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

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Key information

Conditions

Uterine Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Zydolab - Institute of Cytology and Immune Cytochemistry, Dortmund, North Rhine-Westphalia, Germany

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acetic acid test

Diagnostic Test

using acetic acid to unmask dysplastic lesions on the cervix uteri

Lugol's solution test

Diagnostic Test

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

Primary outcomes

  1. additional identified dysplastic lesions on the cervix uteri due to the use of Lugol's Solution

    Time frame: 1 minute

    We count all the cases in which dysplastic lesions on the cervix uteri where identified due to the use

Secondary outcomes

  1. Sensitivity

    Time frame: 1 minute

    sensitivity of the examination (acetic acid + Lugol´s solution)

  2. Specificity

    Time frame: 1 minute

    Specificity of the examination (acetic acid + Lugol´s solution)

  3. PPV

    Time frame: 1 minute

    Positive predictive value of the examination (acetic acid + Lugol´s solution)

  4. NPV

    Time frame: 1 minute

    Negative predictive value of the examination (acetic acid + Lugol´s solution)

Sponsors and collaborators

Lead sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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