Prenatal Test for Fetal Aneuploidy Detection

Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01256606

Enrollment

4000

Registered

2010-12-08

Start date

2010-08-31

Completion date

2011-11-30

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneuploidy, Trisomy 21

Brief summary

The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject is 18yrs or older * Subject has a singleton pregnancy * Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy * Subject is able to provide consent

Exclusion criteria

* Subject is pregnant with more than one fetus * Subject (mother) has known aneuploidy * Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer. * Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.

Design outcomes

Primary

Measure	Time frame	Description
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection	24 months	Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.

Countries

United States

Outcome results