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NIPT C00-002


Title Prospective Collection of Whole Blood Specimens From Pregnant Women at Any Risk of Fetal Chromosomal Anomaly for the Development of a Noninvasive Prenatal Test
Therapeutic Area Fetal Abormalities
Principal Investigator Errol Norwitz, MD, PhD, MBA
Min Age 18 Years
Gender Female
Contact Vidya Iyer
617-636-0186

Overview

The objective of this specimen collection protocol is to obtain whole blood specimens from women with viable pregnancies of at least 10 weeks pregnancy (at any 
risk for fetal chromosomal anomaly) for future testing with an investigational noninvasive prenatal test(s) (NIPTs).

Study Details

Inclusion Criteria

  • Viable current pregnancy of at least 10 weeks GA
  • Maternal age >18
  • Willing and able to provide written consent 

Exclusion Criteria

  • Has prior NIPT result form current pregnancy
  • Had an invasive prenatal diagnostic procedure( CVS, amniocentesis) in current pregnancy before maternal sample collection
  • History of transplant or malignancy

Study Requirements

A subject's participation will take approximately 1 hour for Visit 1. In addition, if cytogenetic results are not available and pregnancy ended in a live birth, it will take approximately 1 hour for Visit 2 (mother's postpartum checkup). 

Study staff will follow subjects until data or specimens used to establish the clinical reference standard are collected, and pregnancy outcome and birth information is collected (if applicable). Follow-up can take up to 40 weeks after enrollment. 

It is anticipated that sites will be enrolling subjects for approximately 4 months. Follow-up will continue for up to 40 weeks after the last subject is enrolled.