Collection of Whole Blood Specimens in Pregnant Women

Illumina

Status: Completed

Conditions: Pregnancy Related

Study type: Observational

Funder types: Industry

Identifiers

NCT03590678

RGH-015

Details and patient eligibility

About

To prospectively collect whole blood specimens and clinical data from pregnant women scheduled for an invasive prenatal diagnostic procedure ("invasive procedure"). Specimens will be used for future testing with an investigational NIPT.

Full description

This is a prospective multicenter study in which whole blood specimens will be collected from pregnant women scheduled for an invasive procedure.

After the standard-of-care invasive procedure is performed in accordance with the site's clinical procedures, invasive prenatal diagnostic procedure results will also be collected.

Enrollment: 3,000 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be 18 years of age or older at enrollment,
• Has a viable pregnancy (with documented fetal heartbeat) of at least 10 weeks, 0 days gestation at the time of maternal specimen collection,
• Be scheduled for an invasive prenatal diagnostic procedure (either chorionic villus sampling [CVS], amniocentesis, or percutaneous umbilical cord blood sampling [cordocentesis]) for cytogenetic analysis of the fetus

Exclusion criteria

• Has a known maternal chromosomal anomaly,
• Had an invasive prenatal diagnostic procedure in the current pregnancy before maternal specimen collection
• Has a history of transplant or malignancy, or
• Had a transfusion of blood or blood components up to 8 weeks before maternal whole blood specimen collection
• Already participated in this study (enrolled previously).

Trial design

3,000 participants in 2 patient groups

1

Description:

Subject is scheduled for an invasive procedure and did not have NIPT testing in current pregnancy

2

Description:

Subject is scheduled for an invasive procedure and has a known positive or no-call result from a targeted NIPT in the current pregnancy