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Prospective Collection of Whole Blood Specimens in Pregnant Women

Title Prospective Collection of Whole Blood Specimens in Pregnant Women
Therapeutic Area Pregnancy
Principal Investigator Errol R. Norwitz, MD, PhD, MBA
Min Age 18 Years
Gender Female
Contact Vidya Iyer, MBBS, CCRP
617-636-0186
viyer1@tuftsmedicalcenter.org
More Information https://www.clinicaltrials.gov/ct2/show/NCT03590678

Overview

To collect blood from pregnant women (should be at least 10 weeks pregnant) who are scheduled for an invasive prenatal diagnostic procedure. Specimens will be used for future testing with an investigational test.

Study Details

Inclusion Criteria

  • Women who are currently pregnant (at least 10 weeks pregnant)
  • Are scheduled for an Invasive procedure ( Amniocentesis, Chorionic Villus sampling, Cordocentesis) and have not had an NIPT or have a positive NIPT result in current pregnancy 
  • Willing and able to provide lnformed consent

Exclusion Criteria

  • Has had a preimplantation genetic diagnostic test
  • Has a known chromosomal anomaly
  • Received blood transfusion or blood products, including RhoGam in the past 8 weeks before enrollment

Study Requirements

A subject's participation will take approximately 1 hour for enrollment and specimen collection. Up to 40 ml of blood (about 4 tubes) will be collected from each subject (minimum required is 10 ml). 

Study staff will passively follow subjects (through medical record review) until cytogenetic results from invasive prenatal diagnostic procedures are captured. Follow-up is expected to take 1 to 11 weeks, depending on when the invasive procedure is performed and the availability of cytogenetic results.