Last updated: 11/03/2018 13:27:16
An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain
GSK study ID
112710
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.
Timeframe: Average time frame: 12 months
Secondary outcomes:
Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up.
Timeframe: Average time frame: 12 months
Behavioural risk factors
Timeframe: During visit 1 (day 0)
Awareness of HPV in relation to transmission and cause of cervical cancer
Timeframe: Average time frame: 12 months
Interventions:
Procedure/surgery: Endocervical samples
Enrollment:
552
Observational study model:
Cohort
Primary completion date:
2011-03-11
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Human Papillomavirus Infection
Product
SB580299
Collaborators
Not applicable
Study date(s)
October 2010 to November 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
16+ years
Accepts healthy volunteers
Yes
- Women ≥ 20 years of age attending a clinic for routine cervical screening OR
- Women ≥ 16 years of age presenting for post-natal check-ups
- 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)
Inclusion and exclusion criteria
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 location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2011-03-11
Actual study completion date
2011-03-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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