Whole Blood Specimen Collection From Pregnant Subjects

Overview

To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2021

Detailed Description

This sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to: 1. be at an increased risk for fetal genetic abnormalities 2. be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy. 3. possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.

Interventions

  • Other: Observational – no intervention

Clinical Trial Outcome Measures

Primary Measures

  • Whole blood collection
    • Time Frame: One or more monthly clinic visits (≥25 days apart) over 13 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits – Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive – Subject is 18 years of age or older – Subject is at an increased risk for one or more of the following: – fetal gene and chromosome abnormalities – congenital fetal infection – known to possess irregular blood group antigens (subject or father of the baby) – known to have some other condition amenable to noninvasive prenatal testing Exclusion Criteria:

  • Pregnancy is non-viable

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Progenity, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.