Prevalence of Abnormal Pap Smear

NCT06641531 | Recruiting

• 1 other identifier: Soh-Med-24-09-13MS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.

Conditions

Cervix Cancer

Outcome Measures

Primary Outcomes (1)

• number of abnormal pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.

  to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.

  From October 2024 to April 2025

Study Arms (2)

Normal group

normal pap smear

Other: Screening pap smear test

Abnormal group

Abnormal routine Pap smears will be classified according to latest Bethesda system into the following categories : Atypical squamous cells of undetermined significance (ASC-US), atypical squamous cells cannot exclude high grade squamous intraepithelial lesion (ASC-H), low grade squamous intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL), squamous cell carcinoma (SCC), atypical glandular cells of undetermined significance (AGUS), and adenocarcinoma (ADC).

Other: Screening pap smear test

Interventions

Screening pap smear test OTHER

The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted. The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain

Abnormal group; Normal group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Gender Eligibility Details: sexually active women of reproductive age.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Non pregnant sexually active women aged from 21 to 60 years old.

You may qualify if:

• Non pregnant sexually active women aged from 21 to 60 years old.
• Patients who didn't have their pap smear done in last 3 years .
• Patient who had previous abnormal pap smear and coming for follow up.

You may not qualify if:

• Women who were diagnosed cervical cancer that was treated.
• Women who underwent total hysterectomy.
• Women who are pregnant.
• Patients whose pap smear was done in last 3 years with reassuring results.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine, Sohag University

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Mostafa radwan, Master

CONTACT

01013774970; mostafa_redwan_post@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Obstetrics and Gynecology department Faculty of Medicine, Sohag University

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)