Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

Sequenom

Status: Terminated

Conditions: Patau Syndrome; Down Syndrome; Turner Syndrome; Edwards Syndrome

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02226315

SQNM-T21-109

Details and patient eligibility

About

This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available;
• Subject was 18 years of age or older at the time of NIPT;
• Subject provides signed and dated informed consent in English;

Exclusion criteria

• Subjects' treating physician is not located in the United States.

Trial design

50 participants in 1 patient group

Multiple gestations

Description:

Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).