Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02226315

Enrollment

Registered

2014-08-27

Start date

2014-08-31

Completion date

2015-09-30

Last updated

2015-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome

Keywords

noninvasive prenatal testing

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay	Subjects contacted within 3 years after pregnancy is completed	Results of the MaterniT21 PLUS LDT will be compared to the pregnancy outcome data obtained from the patient

Countries

United States

Outcome results