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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| Consumer Agreement | The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample. | During testing approximately 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Volunteers requesting a pregnancy test
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| Name | Affiliation | Role |
|---|---|---|
| Kanagaratnam Shanmugaratnam | National Health Service, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bedford General Hospital | Bedford | Bedfordshire | MK42 9DJ | United Kingdom | ||
| Brook clinic |
Overview will be available after study is completed
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnancy Test | Volunteers were instructed to carry out the pregnancy test according to the instruction leaflet and collect a urine sample from the same void into the provided urine container. Volunteers were told to conduct the test according to the instruction leaflet. No other instructions were given. Volunteers were free to choose the "in-stream" or "dip" method of sampling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All volunteers were actively seeking a pregnancy test.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnancy Test | Volunteers were instructed to carry out the pregnancy test according to the instruction leaflet and collect a urine sample from the same void into the provided urine container. Volunteers were told to conduct the test according to the instruction leaflet. No other instructions were given. Volunteers were free to choose the "in-stream" or "dip" method of sampling. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Consumer Agreement | The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample. | 2 volunteers were not included due to insufficient sample. Another volunteer had a error result and there was insufficient sample to repeat. | Posted | Number | percentage of agreement | During testing approximately 15 minutes |
|
Duration of study (December 2010 - June 2011). Each volunteer presented to the study site for 1 hour maximum.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnancy Test | Volunteers were instructed to carry out the pregnancy test according to the instruction leaflet and collect a urine sample from the same void into the provided urine container. Volunteers were told to conduct the test according to the instruction leaflet. No other instructions were given. Volunteers were free to choose the "in-stream" or "dip" method of sampling. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sarah Johnson, Head of Clinical and Regulatory Affairs | SPD Swiss Precision Diagnostics GmbH/SPD Development Company Ltd | 01234835486 | sarah.johnson@spdspark.com |
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Urine samples
| Milton Keynes |
| MK9 2FX |
| United Kingdom |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Educational Status | Count of Participants | Participants | No |
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| Occupation | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
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