Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies
Sponsored by Sequenom, Inc.
About this trial
Last updated 9 years ago
Study ID
SQNM-T21-303
Status
Completed
Type
Observational
Placebo
No
Accepting
18 to 34 Years
Female
Not accepting
Healthy Volunteers
Trial Timing
Ended 10 years ago
What is this trial about?
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.
What are the participation requirements?
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