Trisomy 13 in Fetus, Trisomy 18 in Fetus, Trisomy 21 in Fetus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
The Clinical Trial Company
Axis Shield Diagnostics Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment: 1. Subject is ≥ 18 years of age 2. Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent. 3. Women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm
Exclusion criteria
* A subject is not eligible for participation in the trial if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sample handling | 3 months | Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test. |
Countries
United Kingdom
Outcome results
None listed