Clinical Performance of NIPT in Multiple Gestation Pregnancies

University of Pennsylvania2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Trisomy 21 in Fetus

Interventions

MaterniT21 PLUS and GENOME Laboratory-Developed TestsDEVICE

Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.

Time frame: time from maternal blood draw to delivery

Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.

Time frame: time from maternal blood draw to delivery

Data from ClinicalTrials.gov

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