Specimen Collection for Fetal Aneuploidy Test Development

This study is collecting blood samples from pregnant women to help develop a new, non-invasive test for Down Syndrome and other fetal aneuploidies (having an abnormal number of chromosomes). You may be able to join if you are pregnant between 10 and 22 weeks, are 18 or older, and have an increased risk for fetal aneuploidy. You must also be willing to have a CVS (chorionic villus sampling) or amniocentesis procedure and share the genetic results. The study aims to compare the results from the new blood test with the results from these invasive procedures to see how well the new test works. The current recruitment status is unclear, and the study plans to enroll 2000 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any specific intervention. It plans to include 2000 pregnant women.
What's involved
You would need to provide a blood sample and agree to undergo a CVS and/or amniocentesis procedure. You would also need to provide the genetic results from that procedure.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT01429389

Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy

Recruiting
Not specifiedAges 18+Observational
Sequenom, Inc.
~2,000 participants
Updated 2024-10-16 on ClinicalTrials.gov

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring

A primary outcome measure isn't published for this study.

Down Syndrome
Fetal Aneuploidy
14 sites across 9 states
California5
Michigan2
Alabama1
Illinois1
Iowa1
New Jersey1
South Carolina1
Nova Scotia1
  • Daniel Grosu, MD · STUDY_DIRECTOR · Sequenom, Inc.

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Eligibility criteria

Inclusion

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
subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis
subject agrees to provide the genetic results of the invasive procedure

Exclusion

Fetal demise at time of specimen sampling
Previous sample donation under this protocol