An observational study in Pregnancy, sponsored by SPD Development Company Limited. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by SPD Development Company Limited · Observational
The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. This study will assess the performance of a HPT in the hands of lay-users by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.
The Clearblue product is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. The test is indicated for use from 6 days before the day of the missed period (5 days before the day of the expected period). The test is intended for home use.
This study aims to demonstrate that the Pregnancy Test has the required performance characteristics in lay-user testing, and when testing samples provided by lay-users. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged between 18 and 45 representative of the intended user.
A minimum of 204 volunteers will be required to complete the study. The study site will aim to recruit an equal number of pregnant and not-pregnant volunteers (a minimum of 102 of each). Each volunteer will conduct the pregnancy test using both the 'in stream' and 'dip' method of sampling. Volunteer results will be evaluated against confirmed pregnancy status.
SPD Development Company Limited is the lead sponsor of 30 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy pregnant, or not pregnant volunteers requiring or wishing to conduct a pregnancy test.
Exclusion Criteria:
Urine pregnancy test
Accuracy of Clearblue pregnancy test
Number of pregnancy test results in agreement with clinical pregnancy status
Time frame: 3 days
Sample method agreement
number of volunteers who record the same pregnancy test result using the 'in stream' and 'dip' method of sampling
Time frame: 1 day
Coordinator agreement
number of volunteers who record the same pregnancy test result as a trained study coordinator
Time frame: 1 day
Device usability
number of volunteers who record the device as easy to use
Time frame: 1 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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SPD Development Company Limited