OHSU

PreNATUS: Prenatal Non-invasive Aneuploidy Testing Utilizing SNPs Study

Clinical Trial Seeking Participants

IRB 9017 (PI: Leonardo Pereira, MD, MCR)

The Maternal Fetal Medicine Research Unit is participating in a study to learn more about new first trimester genetic screening tests.

Trial Status:

Open to Enrollment

Why is this study being done?

Many women choose to have routine prenatal screening during the first trimester of pregnancy to see if there may be any problems related to development of the fetus such as a chromosomal condition. Chromosomes are long strands of genes located in all of the human body cells. Genes are the units of DNA--the chemical structure carrying your genetic information--that determine many human characteristics such as the color of your eyes, your height, and whether you are male or female. The current routine screening includes an ultrasound and/or a blood test.

If the routine screening results are positive, then a pregnant woman often meets with her care providers to decide about invasive diagnostic testing like chorionic villous sampling (CVS) or amniocentesis.

The sponsor of this study, Natera Inc. and the National Institute of Health, has an experimental blood test that detects fetal DNA in a mother’s blood and may help improve the accuracy of prenatal screening. The PreNATUS study will enroll both the pregnant mother and the father of the baby, if they are planning to have an invasive genetic test (amniocentesis or a CVS). The purpose is to determine the diagnostic capability of the study test, in other words, how well it works. Because the blood test is still under investigation, the results of the experimental test will not be available to patients or their care providers. Participation in this study will not change a woman’s prenatal care or cause her doctor or midwife to make different recommendations about their pregnancy.

The purpose of this study is to:

The diagnostic capability of an experimental blood test that detects fetal DNA in mother’s blood, and uses genetic information from the mother sample and the father sample to detect pregnancies with chromosome abnormalities in the fetus (like Down Syndrome).

Who is eligible to participate?

Women who are between 18 and 56 years old with:

  • A singleton pregnancy
  • Be pregnant between 8 weeks - 24 weeks
  • Plans to have an invasive genetic testing (amniocentesis or CVS)
  • A Nuchal Translucency (NT) measurement of 3.0 mm or greater
  • Father of the baby is willing to provide a sample (blood sample or cheek swab)

What is the compensation for this study?

Each consented couple will receive $50.00 compensation for their participation.

Whom do I contact for more information?

To find out more information and to learn if you are qualified to participate, email our Research Coordinator, Monica Rincon, at Rincon@ohsu.edu or call 503 494-8748