Pregnancy
Conditions
Keywords
Pregnancy test, Wishing to become pregnant
Brief summary
The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information.
Detailed description
Approximately 800 female volunteers wishing to become pregnant will be recruited locally around 5 trial centers within the US. Daily urine samples and gestational age dating scan information obtained from the study will be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product assessment will involve testing of early morning urine samples collected by women during the cycle in which they conceived. Urine samples will be collected pre-conception to the end of the second trimester.
Interventions
None listed
Sponsors
SPD Development Company Limited
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Provide written informed consent to participate in the study and agree to comply with study procedures. * Has menstrual bleeds. * Seeking to become pregnant. * Intend to seek medical care during pregnancy.
Exclusion criteria
* Has positive pregnancy test on screening. * Has received medical treatment for infertility or is participating in an assisted fertility program. * Known condition to contra-indicate pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy. | 1 year |
Countries
United States
Outcome results
None listed