MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy (MELISSA)

Verinata Health

Status: Completed

Conditions: Prenatal Care; Pregnant Women

Study type: Observational

Funder types: Industry

Identifiers

NCT01122524

ART-0006

Details and patient eligibility

About

The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).

Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.

Enrollment: 10,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Clinically confirmed viable pregnancy at the time of enrollment
• Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
• Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
• Able to provide consent for participation using language appropriate forms and consent process

Exclusion criteria

• Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment

Trial design

10,000 participants in 2 patient groups

Chromosomal Abnormality

Description:

Fetus affected by chromosomal abnormality

No Chromosomal Abnormality

Description:

Fetus not affected by chromosomal abnormality