Prevalence of Abnormal Pap Smear

Sohag University

Status: Enrolling

Conditions: Cervix Cancer

Treatments: Other: Screening pap smear test

Study type: Observational

Funder types: Other

Identifiers

NCT06641531

Soh-Med-24-09-13MS

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Normal group

Description:

normal pap smear

Treatment:

Other: Screening pap smear test

Abnormal group

Description:

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).

Treatment:

Other: Screening pap smear test