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

November 21, 2012 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

552

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahrain
      • Manama, Bahrain
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women ≥ 20 years of age, attending out-patient health services for routine cervical screening and women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Assessed Cohort
Subjects attending out-patient health services for routine cervical screening or presenting for post-natal check up
Procedure: Endocervical samples
Endocervical samples collection during routine gynaecological examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.
Time Frame: Average time frame: 12 months
Average time frame: 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up.
Time Frame: Average time frame: 12 months
Average time frame: 12 months
Behavioural risk factors
Time Frame: During visit 1 (day 0)
During visit 1 (day 0)
Awareness of HPV in relation to transmission and cause of cervical cancer
Time Frame: Average time frame: 12 months
Average time frame: 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 17, 2010

First Posted (Estimate)

September 20, 2010

Study Record Updates

Last Update Posted (Estimate)

November 22, 2012

Last Update Submitted That Met QC Criteria

November 21, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112710

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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