Clinical Performance of NIPT in Multiple Gestation Pregnancies

Overview

This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.

Full Title of Study: “Clinical Performance of NIPT (Noninvasive Prenatal Testing) in Multiple Gestation Pregnancies (SCMM-T21-110)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: November 15, 2021

Interventions

  • Device: MaterniT21 PLUS and GENOME Laboratory-Developed Tests
    • Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.

Arms, Groups and Cohorts

  • Pregnancies with multiple gestations

Clinical Trial Outcome Measures

Primary Measures

  • Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations.
    • Time Frame: time from maternal blood draw to delivery
  • Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations.
    • Time Frame: time from maternal blood draw to delivery

Participating in This Clinical Trial

Inclusion Criteria

  • subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories; – subject was 18 or older at the time of NIPT Exclusion Criteria:

  • none

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Collaborator
    • Sequenom, Inc/Laboratory Corporation of America Holdings
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lorraine Dugoff, Professor of Obstetrics and Gynecology – University of Pennsylvania

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