Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

Sponsor

Sequenom, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02226315

Collaborator

Friends Research Institute, Inc. (Other)

Enrollment

Location

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome Edwards Syndrome Patau Syndrome Turner Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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;