Clinical trial NCT01577901: Consumer in Stream and Container Collected Study
Official title: Consumer in Stream and Container Collected Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Determination of Pregnancy Status
Keywords: Pregnancy
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Female volunteers, requiring to conduct a personal pregnancy test will use Clearblue Advanced Pregnancy test, following the instructions for use. The test will be conducted following both the instructions for the in stream method of sampling and the method of testing when a sample is collected into a container. The results will be compared to those achieved by the study technician.

Detailed description: The study will compare the performance of the Clearblue Advanced Pregnancy Test, when used by consumers according to the instructions for use leaflet (IFUL), and by trained coordinators. Consumer testing will include both sampling in the urine stream and the testing method for urine collected into a container.

In addition, the performance of the Clearblue Advanced Pregnancy Test will be compared to that of the currently marketed Clearblue Digital Pregnancy Test for the detection of pregnancy. In this comparison, both tests will be performed by a trained coordinator using the testing method for urine collected into a container on each volunteer's urine sample.

The study will involve the recruitment of a cross-section of the target pregnancy test users in the United Kingdom, that is, women aged 18-45 who are seeking a pregnancy test. The study will aim to recruit at least 100 volunteers, a minimum of 30 (30%) of whom will be pregnant.

Volunteers will use the Clearblue Advanced Pregnancy Test device using the urine stream method of sampling according to the product instructions. In addition volunteers will be asked to collect a urine sample from the same void and conduct a second Clearblue Advanced Pregnancy Test, using the testing method for urine collected in a container. The volunteer will then complete a study questionnaire on ease of use and leaflet comprehension. The questionnaire, urine sample and used devices will be retained by SPD for evaluation Agreement between the volunteer Pregnancy Test result and study coordinator Pregnancy Test result will be reported.

Eligibility criteria: Inclusion Criteria:

* Requiring a pregnancy test
* Willing to provide informed consent and reveal pregnancy status

Exclusion Criteria:

* Employees of SPD. Unipath, Alere or P\&G Previous participation in study Previously used Clearblue Advanced Pregnancy Test.

Primary outcomes:
measure: number of pregnant volunteers as determined by volunteer test result.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd.
state: Bedfordshire
Study officials:
affiliation: SPD Development Company Limited
name: Pauline A Parkinson, BSc
role: PRINCIPAL_INVESTIGATOR
References: