Prevalence of Abnormal Pap Smear

Prevalence of Abnormal Pap Smear in Sohag University Hospital Outpatient Clinic

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

Study Overview

• Status: Recruiting
• Conditions: Cervix Cancer
• Intervention / Treatment: Other: Screening pap smear test

Detailed Description

This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending Sohag university hospital outpatient clinic. Participating women will be subjected to accurate history taking regarding age, parity, Body mass index, contraceptive use, menstrual history, and duration of marital life, frequency of previous marriages if any, and the status of cervix by per-vaginal examination of the patients.

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 . The Bethesda System will be used for cytological interpretation.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Mostafa radwan, Master; Phone Number: 01013774970; Email: mostafa_redwan_post@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Faculty of Medicine, Sohag University
    • Contact: Mostafa redwan, master; Phone Number: 0101374970; Email: mostafa_redwan_post@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal group; normal pap smear	Other: Screening pap smear test; 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: October 12, 2024
• First Submitted That Met QC Criteria: October 12, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 12, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: Soh-Med-24-09-13MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No