Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSequenom, Inc.
About this trial
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
pregnant between 10 and 22 weeks gestation
18 years of age or older
provides signed and dated informed consent
subject is at increased risk for fetal aneuploidy
Disqualifiers
Fetal demise at time of specimen sampling
Previous sample donation under this protocol
Trial population
Pregnant women between 10 and 22 weeks of gestation who are scheduled to undergo a CVS or amniocentesis procedure and will receive the fetal FISH, karyotype and/or QF-PCR results from the procedure.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Collect samples and data for assay validation.
Sensitivity and Specificity
Time frame
9-24 weeks of gestatational ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov