A Study Collecting Blood Samples From Pregnant Women to Aid in the Development of a Noninvasive Prenatal Test

Completed

Conditions studied: Pregnancy

In brief

The purpose of this study is to collect whole blood samples from women with viable pregnancies of at least 10 weeks gestation (at any risk for fetal chromosomal anomaly) for future testing with an investigational noninvasive prenatal test(s) (NIPTs), and to establish clinical truth compared to a clinical reference standard.

Key facts

Study ID

NCT03620110

Run by

Illumina, Inc.

People needed

2209

Starts

2018-05-21

Expected to finish

2019-12-30

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Has a viable pregnancy of at least 10 weeks, 0 days gestation at the time of maternal specimen collection (singleton or multiple pregnancy acceptable),
• Be 18 years of age or older at enrollment, and
• Is willing and able to provide documentation of informed consent.

You may not qualify if…

• Has a prior NIPT result from the current pregnancy,
• Had an invasive prenatal diagnostic procedure (eg, CVS, amniocentesis) in the current pregnancy before maternal specimen collection,
• Has a history of transplant or malignancy,
• Had a transfusion of blood or blood components up to 8 weeks before maternal specimen collection,
• Had preimplantation genetic screening for the current pregnancy (for in vitro fertilization patients only), or
• Has already participated in the study (enrolled previously)

Where it is running

• Valley Perinatal Services — Phoenix, Arizona, United States
• Unified Women's Clinical Research - Hagerstown — Hagerstown, Maryland, United States
• United Women's Clinical Research-Greensboro — Greensboro, North Carolina, United States
• Unified Women's Clinical Research - Morehead City — Morehead City, North Carolina, United States
• Unified Women's Clinical Research - Raleigh — Raleigh, North Carolina, United States
• Unified Women's Clinical Research - Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• Jackson Clinic — Jackson, Tennessee, United States
• The Group for Women — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.