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Multiple Gestation Study

NCT02278536 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 354

Last updated 2019-08-26

No results posted yet for this study

Summary

The objectives of the clinical study are to demonstrate the accuracy of our new NATUS diagnostic 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 any currently available screening tests. This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated with a risk of miscarriage.

Conditions

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

Sponsors & Collaborators

  • Houston Perinatal Associates

    collaborator UNKNOWN

  • Lyndhurst Clinical Research

    collaborator UNKNOWN

  • Dr. Carpenter Maternal Fetal Medicine Clinic

    collaborator UNKNOWN

  • San Diego Perinatal Center

    collaborator UNKNOWN

  • Natera, Inc.

    lead INDUSTRY

Principal Investigators

  • Brian Kirshon, MD · Houston Perinatal Associates

  • Robert Lamar Parker, MD · Lyndhurst Clinical Research

  • Robert Carpenter, MD · Office of Dr. Robert Carpenter

  • Zach Demko, PhD · Natera, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • United States
  • India
  • Malaysia

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 NCT02278536 on ClinicalTrials.gov