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Completed

NCT Number: NCT01205412

An Observational Study on the Prevalence of Human Papillomavirus 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.

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Key information

Conditions

Human Papillomavirus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site

Manama, Bahrain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endocervical samples

Procedure

Endocervical samples collection during routine gynaecological examinations

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Behavioural risk factors

    Time frame: During visit 1 (day 0)

  3. Awareness of HPV in relation to transmission and cause of cervical cancer

    Time frame: Average time frame: 12 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 20, 2010
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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