Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies



Status:Terminated
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2014
End Date:September 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Retrospective Analysis of Fetal Outcome Compared to Massively Parallel Sequencing Test Results Obtained From Multiple Gestation Pregnancies at Increased Risk for Fetal Chromosomal Aneuploidy

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.


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.
We found this trial at
1
site
Presbyterian - St. Luke's Medical Center
1719 East 19th Avenue
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
?
mi
from
Denver, CO
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