Clearblue Home Pregnancy Test Consumer Study
| Tracking Information | |||||
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| First Received Date ICMJE | December 24, 2010 | ||||
| Last Updated Date | September 27, 2011 | ||||
| Start Date ICMJE | December 2010 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Consumer agreement [ Time Frame: Completion of laboratory testing ] [ Designated as safety issue: No ] The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01279486 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clearblue Home Pregnancy Test Consumer Study | ||||
| Official Title ICMJE | Clearblue Home Pregnancy Test Consumer Study | ||||
| Brief Summary | Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to the UK trial centre. Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void. Trained technicians will conduct a second test from the urine sample. |
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| Detailed Description | Approximately 120 female volunteers attending the study site requesting a pregnancy test will be recruited locally to the UK trial centre. Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void. Trained technicians will conduct a second test from the urine sample to evaluate performance between consumer and technician testing. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Urine samples |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Volunteers requesting a pregnancy test |
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| Condition ICMJE | Pregnancy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: |
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01279486 | ||||
| Other Study ID Numbers ICMJE | PROTOCOL-0187 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | SPD Development Company Limited | ||||
| Study Sponsor ICMJE | SPD Development Company Limited | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | SPD Development Company Limited | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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