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High Risk Multiple Gestation Study

NCT02278874 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 99

Last updated 2019-06-13

No results posted yet for this study

Summary

The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than other currently available screening tests.

This will result in fewer unnecessary amniocenteses and Chorionic Villus Sample (CVS) procedures, which are associated with a risk of miscarriage.

Conditions

  • Trisomy 13
  • Trisomy 18
  • Trisomy 21
  • Sex Chromosome Abnormalities

Sponsors & Collaborators

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • Montefiore Medical Center

    collaborator OTHER

  • Long Island Jewish Medical Center

    collaborator OTHER

  • Tufts Medical Center

    collaborator OTHER

  • Natera, Inc.

    lead INDUSTRY

Principal Investigators

  • Joanne Stone, MD · Mt. Sinai Hospital, New York

  • Peer Dar, MD · Montefiore Medical Center

  • Rajeevi Madankumar, MD · Long Island Jewish Medical Center

  • Errol Norwitz, MD, PhD · Tufts Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-12-01
Completion
2019-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02278874 on ClinicalTrials.gov