An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Human Papillomavirus Infection

Treatments: Procedure: Endocervical samples

Study type: Observational

Funder types: Industry

Identifiers

NCT01205412

112710

Details and patient eligibility

About

The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.

Enrollment: 552 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women ≥ 20 years of age attending a clinic for routine cervical screening OR
• Women ≥ 16 years of age presenting for post-natal check-ups
• Women providing a cervical sample
• Written informed consent or oral-witnessed thumb printed informed consent obtained from the subject

Exclusion criteria

• Referral for abnormal cervical sample at the current visit
• Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed (Note: Enrolment can be delayed until this condition is resolved)
• Pregnant women
• History of hysterectomy
• Known diagnosis of immunosuppression, or patient on immunosuppressives
• Having received one or more doses of human papillomavirus vaccine prior to participating in the study

Trial design

552 participants in 1 patient group

Assessed Cohort

Description:

Subjects attending out-patient health services for routine cervical screening or presenting for post-natal check up

Treatment:

Procedure: Endocervical samples