Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies

Terminated

• Conditions: Turner Syndrome; Down Syndrome; Edwards Syndrome; Patau Syndrome

• Registration Number: NCT02226315
• Lead Sponsor: Sequenom, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-27
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-15
• Last Update Posted: 2015-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Presbyterian/St. Luke's Medical Center; 🇺🇸 Denver, Colorado, United States