Pregnancy
Conditions
Keywords
Pregnancy,
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.
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.
Interventions
None listed
Sponsors
SPD Development Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-45 year old * Female * Requesting a pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consumer Agreement | During testing approximately 15 minutes | The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Pregnancy Test |
|---|---|
| Age, Customized Age 18-25 | 96 Participants |
| Age, Customized Age 26-30 | 11 Participants |
| Age, Customized Age 31-35 | 5 Participants |
| Age, Customized Age 36-40 | 5 Participants |
| Age, Customized Age 41-45 | 3 Participants |
| Educational Status A levels, vocational level 3 and equivalents | 31 Participants |
| Educational Status Degree, or equivalent, and above | 12 Participants |
| Educational Status GCSE (grade A*-C), vocational level 2 and equivale | 45 Participants |
| Educational Status No qualifications | 10 Participants |
| Educational Status Other higher education below degree level | 13 Participants |
| Educational Status Other qualifications | 5 Participants |
| Educational Status Qualifications at level 1 or below | 2 Participants |
| Educational Status Unclear | 2 Participants |
| Occupation Administrative / Secretarial | 7 Participants |
| Occupation Associate Professional / Technical | 0 Participants |
| Occupation Homemaker | 14 Participants |
| Occupation Managerial | 7 Participants |
| Occupation Manufacturing / Driver | 1 Participants |
| Occupation Other | 28 Participants |
| Occupation Personal Services | 1 Participants |
| Occupation Professional | 10 Participants |
| Occupation Sales / Customer Services | 21 Participants |
| Occupation Skilled Trade | 0 Participants |
| Occupation Student | 29 Participants |
| Occupation Support Personnel | 0 Participants |
| Occupation Unclear (ticked more than one category) | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 15 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Mixed | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 94 Participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Consumer Agreement
The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample.
Time frame: During testing approximately 15 minutes
Population: 2 volunteers were not included due to insufficient sample. Another volunteer had a error result and there was insufficient sample to repeat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnancy Test | Consumer Agreement | 100 percentage of agreement |