Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 34 |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | December 2015 |
A Clinical Study to Evaluate the Relative Clinical Specificity Performance of the SEQureDx Trisomy Test in Pregnant Women at Low Risk for Fetal Chromosomal Aneuploidy
Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled.
Study blood will be collected in the first or second trimester at a scheduled prenatal
screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will
be followed until delivery and the birth outcome recorded.
Study blood will be collected in the first or second trimester at a scheduled prenatal
screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will
be followed until delivery and the birth outcome recorded.
Inclusion Criteria:
- Pregnancy is 10-22 weeks gestation
- Between 18-34 years of age inclusive at estimated date of delivery
- No prenatal screening indicators for high risk including serum biochemical and
ultrasound screening
- No personal or family history of Down syndrome
- Willing to provide written informed consent
- Willing to provide a whole blood sample
- Willing to provide access to medical records supporting fetal outcome
Exclusion Criteria:
- Fetal demise at the time of the blood draw
- Previous specimen donation under this protocol
We found this trial at
27
sites
University of South Alabama "University of South Alabama is a public institution that was founded...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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