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

Human Papillomavirus Infection Clinical Trial

Official title:

An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205412
• Other study ID #: 112710
• Status: Completed
• Phase: N/A
• First received: September 16, 2010
• Last updated: November 21, 2012
• Start date: October 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kingdom of Bahrain: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Procedure:
• Endocervical samples
Endocervical samples collection during routine gynaecological examinations

Locations

Country	Name	City	State
Bahrain	GSK Investigational Site	Manama

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Bahrain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.		Average time frame: 12 months	No
Secondary	Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up.		Average time frame: 12 months	No
Secondary	Behavioural risk factors		During visit 1 (day 0)	No
Secondary	Awareness of HPV in relation to transmission and cause of cervical cancer		Average time frame: 12 months	No