High Risk Multiple Gestation Study

June 11, 2019 updated by: Natera, Inc.

Development of Non-invasive Prenatal Diagnostic Test for Multiple Gestation Pregnancies Based on Fetal DNA Isolated From Maternal Blood

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Glen Cove, New York, United States, 11542
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10029
        • Mt. Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pregnant Women

Description

Inclusion Criteria:

  • Age 18 or older at enrollment
  • Clinically confirmed multiple gestation pregnancy

  • Pregnancy at high risk for genetic aneuploidy as defined below:

    • Confirmed positive aneuploidy by invasive testing
    • Non invasive prenatal testing "high risk" result
    • Serum screening risk of greater than 1:100

    • Ultrasound abnormalities indicative of aneuploidy

      • Structural abnormality of the posterior fossa
      • Holoprosencephaly
      • Structural cardiac anomaly
      • Omphalocele
      • Nuchal translucency greater than or equal to 3.5 mm or a nuchal fold greater Hydrops of unknown etiology
    • Age ≥ 38 years at delivery (if serum screening risk is not less than 1:100)
  • Gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate
  • Able to provide informed consent

Exclusion Criteria:

  • Women carrying singleton pregnancy
  • Surrogate or egg donor used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Multiple gestation high risk pregnancies
women pregnant with twins or triplets at high risk for aneuploidy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening capability of proprietary algorithm in the form of a risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.'
Time Frame: 4 years

The primary outcome will be to confirm the diagnostic capability of NATUS risk results (a risk score eg 1:100) classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.' The outcome will be determined as a risk score given for samples collected. This outcome will be compared to the diagnostic testing results of ploidy status.

The chromosomal status will be determined from the CVS or amniocentesis results, if available. A cheek swab or saliva sample will be collected from live-born children if there are no CVS or amniocentesis results. This will be used to determine the true ploidy status of the fetuses.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natera, Inc.

Collaborators

Montefiore Medical Center
Tufts Medical Center
MOUNT SINAI HOSPITAL
Long Island Jewish Medical Center

Investigators

  • Principal Investigator: Peer Dar, MD, Montefiore Medical Center
  • Principal Investigator: Joanne Stone, MD, Mt. Sinai Hospital, New York
  • Principal Investigator: Rajeevi Madankumar, MD, Long Island Jewish Medical Center
  • Principal Investigator: Errol Norwitz, MD, PhD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-016B-NPT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trisomy 21

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe