Trial Outcomes & Findings for Clearblue Home Pregnancy Test Consumer Study (NCT NCT01279486)
NCT ID: NCT01279486
Last Updated: 2018-11-02
Results Overview
The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample.
Recruitment status
COMPLETED
Target enrollment
120 participants
Primary outcome timeframe
During testing approximately 15 minutes
Results posted on
2018-11-02
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
|
120
|
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Overall Study
COMPLETED
|
119
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Lost to Follow-up
|
1
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Baseline Characteristics
Clearblue Home Pregnancy Test Consumer Study
Baseline characteristics by cohort
| Measure |
Pregnancy Test
n=120 Participants
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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|---|---|
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Age, Customized
Age · 18-25
|
96 Participants
n=5 Participants
|
|
Age, Customized
Age · 26-30
|
11 Participants
n=5 Participants
|
|
Age, Customized
Age · 31-35
|
5 Participants
n=5 Participants
|
|
Age, Customized
Age · 36-40
|
5 Participants
n=5 Participants
|
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Age, Customized
Age · 41-45
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Mixed
|
3 Participants
n=5 Participants
|
|
Educational Status
Degree, or equivalent, and above
|
12 Participants
n=5 Participants
|
|
Educational Status
Other higher education below degree level
|
13 Participants
n=5 Participants
|
|
Educational Status
A levels, vocational level 3 and equivalents
|
31 Participants
n=5 Participants
|
|
Educational Status
GCSE (grade A*-C), vocational level 2 and equivale
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45 Participants
n=5 Participants
|
|
Educational Status
Qualifications at level 1 or below
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2 Participants
n=5 Participants
|
|
Educational Status
Other qualifications
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5 Participants
n=5 Participants
|
|
Educational Status
No qualifications
|
10 Participants
n=5 Participants
|
|
Educational Status
Unclear
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2 Participants
n=5 Participants
|
|
Occupation
Managerial
|
7 Participants
n=5 Participants
|
|
Occupation
Professional
|
10 Participants
n=5 Participants
|
|
Occupation
Associate Professional / Technical
|
0 Participants
n=5 Participants
|
|
Occupation
Administrative / Secretarial
|
7 Participants
n=5 Participants
|
|
Occupation
Skilled Trade
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0 Participants
n=5 Participants
|
|
Occupation
Personal Services
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1 Participants
n=5 Participants
|
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Occupation
Sales / Customer Services
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21 Participants
n=5 Participants
|
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Occupation
Manufacturing / Driver
|
1 Participants
n=5 Participants
|
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Occupation
Support Personnel
|
0 Participants
n=5 Participants
|
|
Occupation
Student
|
29 Participants
n=5 Participants
|
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Occupation
Homemaker
|
14 Participants
n=5 Participants
|
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Occupation
Other
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28 Participants
n=5 Participants
|
|
Occupation
Unclear (ticked more than one category)
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2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During testing approximately 15 minutesPopulation: 2 volunteers were not included due to insufficient sample. Another volunteer had a error result and there was insufficient sample to repeat.
The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample.
Outcome measures
| Measure |
Pregnancy Test
n=117 Participants
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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|---|---|
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Consumer Agreement
|
100 percentage of agreement
|
Adverse Events
Pregnancy Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Sarah Johnson, Head of Clinical and Regulatory Affairs
SPD Swiss Precision Diagnostics GmbH/SPD Development Company Ltd
Phone: 01234835486
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place