Clinical Performance of NIPT in Multiple Gestation Pregnancies

University of Pennsylvania

Status: Completed

Conditions: Trisomy 21 in Fetus

Treatments: Device: MaterniT21 PLUS and GENOME Laboratory-Developed Tests

Study type: Observational

Funder types: Other

Identifiers

NCT04488393

SCMM-T21-110

Details and patient eligibility

About

This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.

Enrollment: 2,000 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories;
• subject was 18 or older at the time of NIPT

Exclusion criteria

• none

Trial design

2,000 participants in 1 patient group

Pregnancies with multiple gestations

Treatment:

Device: MaterniT21 PLUS and GENOME Laboratory-Developed Tests