Collection of Whole Blood Specimens from Pregnant Women At Increased Risk of Fetal Chromosomal Abnormality for Developing a Noninvasive Prenatal Test Using Circulating Cell-Free DNA

What this Trial Is About

Researchers are collecting blood specimens from pregnant women who are at increased risk for fetal chromosomal abnormalities, such as Down Syndrome, to help develop a noninvasive prenatal test. This test aims to analyze circulating cell-free fetal DNA from the mother's blood to detect fetal chromosomal aneuploidy. The study compares the new test results with those obtained from standard invasive procedures like chorionic villus sampling (CVS) or genetic amniocentesis. Participants will provide blood samples during their pregnancy between 10 and 22 weeks of gestation. These samples will be analyzed to measure the relative quantity of chromosomal material in fetal DNA circulating in the mother's plasma. Alongside, participants will undergo CVS and/or amniocentesis to collect genetic material for comparison. This observational study does not involve any experimental treatments. During the study, women will give informed consent and provide genetic results from the invasive diagnostic procedures. Researchers will collect and compare blood specimens and genetic testing data. The study involves no intervention beyond these collections and lasts through the period needed to gather and analyze specimens. Participants' health and pregnancy outcomes will be monitored as part of standard care.

Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy