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NCT Number: NCT07692919

VIA Versus Colposcopy

The aim of this study is to compare the effectiveness of visual inspection with acetic acid (VIA) versus colposcopy in terms of sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women, and to assess the awareness of women regarding cervical cancer screening methods.

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Key information

About this study

Method of study:

Medical and surgical history of the patients will be taken, clinical examinations of the patients will be performed and routine laboratory investigations will be done.

Patients will be asked to empty their bladder and positioned in the lithotomy or dorsal supine position on the examination table. Standard infection control measures will be followed, including hand hygiene and use of sterile gloves and speculum.

Visual Inspection with Acetic Acid (VIA) VIA will be conducted by trained gynecology residents under consultant supervision. A 5% acetic acid solution will be applied to the cervix, and after one minute, the cervix will be inspected under adequate light. The appearance of acetowhite areas will be considered VIA positive, indicating possible precancerous changes.

Colposcopy Women who are candidate for colposcopy assessment or with abnormal Pap smear will be referred for colposcopic evaluation using a binocular colposcope (magnification: 5×, 10×, and 20×) with a green filter to assess vascular patterns.

Lesions will be scored using the Swede score, an open access validated colposcopic scoring system based on five criteria: uptake of acetic acid, margins and surface, vessels, lesion size, and iodine staining Scores 0-4: normal or low-grade lesion (CIN 1 or less) Scores 5-6: possible high-grade lesion (CIN 2) Scores 7-10: high-grade lesion/CIN 3 or invasive cancer (11). Biopsy and Histopathology Colposcopy-guided biopsies will be performed only in patients with a Swede score ≥ 5, following standard protocols to avoid unnecessary invasive procedures in low-grade lesions. Biopsy specimens will be fixed in 10% formalin, processed, stained with hematoxylin and eosin, and examined under light microscopy.

Histopathological findings will be classified as:

Chronic cervicitis CIN 1, CIN 2, CIN 3 Carcinoma in situ Squamous cell carcinoma (SCC) Adenocarcinoma Classification followed WHO standards (12).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age from 25 to 65 years.
  • Patient undergoing cervical cancer screening using VIA and colposcopy.
  • Women with symptoms such as white discharge, post-coital bleeding, and intermenstrual bleeding.
  • Women with the clinically unhealthy cervix (erosion, bleeding on touch, simple leukoplakia, keratinization)
  • Women with Pap smear showing dysplasia.

Exclusion criteria

  • • Pregnant women (if VIA or colposcopy is contraindicated).
  • Women with obvious invasive cervical cancer diagnosed previously.
  • Women who refuse to provide informed consent or are unable to cooperate with the examination.
  • Women having active vaginal bleeding.
  • Any past treatment for cervical lesions.

Treatment and study plan

VIA

Other

A 5% acetic acid solution will be applied to the cervix, and after one minute, the cervix will be inspected under adequate light

Primary outcomes

  1. VIA Versus Colposcopy in terms of in terms of sensitivity and specificity

    Time frame: 2 weeks

    Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy.

    All patients will be advised on post-procedure care, including avoiding vaginal do

  2. sensitivity and specificity in diagnosis of pre-malignant cervical lesions among women

    Time frame: From enrollment to the the result at 14 days

    Patients will be observed for any immediate discomfort or minor complications such as spotting, mild cramping, or vaginal irritation following VIA, colposcopy, or biopsy.

    All patients will be advised on post-procedure care, including avoiding vaginal douching, sexual activity, or use of tampons for a few days, if a biopsy will be performed.

    Results of the VIA, colposcopy, and histopathology will be explained to the patients, and appropriate follow-up or referral will be arranged for those with CIN 2, CIN 3, or carcinoma.

    Patients will be instructed to report any unusual bleeding, pain, or discharge immediately to the clinic.

Study contacts

Contact information is provided by the study sponsor or research team.

bassam mahmoud abdallah Mahmoud Abdallah, resident

CONTACT

[email protected]

+201012200274

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Visual Inspection With Acetic Acid of The Cervix Versus Colposcopy in Screening and Detection of Cervical Intraepithelial Neoplasia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

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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