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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01205412
First received: September 16, 2010
Last updated: November 21, 2012
Last verified: November 2012

September 16, 2010
November 21, 2012
October 2010
November 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Prevalence of any Human Papillomavirus (HPV) DNA and HPV type distribution among women undergoing cervical sample testing and post-natal check up. [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01205412 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Behavioural risk factors [ Time Frame: During visit 1 (day 0) ] [ Designated as safety issue: No ]
  • Awareness of HPV in relation to transmission and cause of cervical cancer [ Time Frame: Average time frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Endocervical samples

Non-Probability Sample

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.

Human Papillomavirus Infection
Procedure: Endocervical samples
Endocervical samples collection during routine gynaecological examinations
Assessed Cohort
Subjects attending out-patient health services for routine cervical screening or presenting for post-natal check up
Intervention: Procedure: Endocervical samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
552
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Female
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Bahrain
 
NCT01205412
112710
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP