Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

Stopped early

Conditions studied: Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome

In brief

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.

Key facts

Study ID

NCT02226315

Run by

Sequenom, Inc.

People needed

50

Starts

2014-08-01

Expected to finish

2015-09-01

Last updated by the study team

2015-09-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

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

Where it is running

• Presbyterian/St. Luke's Medical Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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