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| Name | Class |
|---|---|
| The Clinical Trial Company | INDUSTRY |
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Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.
Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required.
Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.
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| Measure | Description | Time Frame |
|---|---|---|
| Sample handling | Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test. | 3 months |
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Inclusion Criteria:
A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:
Exclusion Criteria:
A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment:
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First trimester pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Robson | Professor of Fetal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newcastle University | Newcastle upon Tyne | UK | NE24HH | United Kingdom |
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Serum