Multiple Gestation Study

August 21, 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 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

354

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

  • India
      • Bangalore, India
        • Bangalore Fetal Medicine Centre
  • Malaysia
    • Selangor
      • Petaling Jaya, Selangor, Malaysia
        • Fetal Medicine & Gynaecology Centre
  • United States
    • California
      • San Carlos, California, United States, 94070
        • Natera, Inc.
      • San Diego, California, United States, 92123
        • San Diego Perinatal Center
    • New York
      • New York, New York, United States, 10128
        • Carnegie Hill Imaging for Women
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
    • Texas
      • Houston, Texas, United States, 77030
        • Office of Dr. Robert Carpenter
      • Houston, Texas, United States, 77054
        • Houston Perinatal Associates

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

No

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
  • 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome will be to confirm the diagnostic capability of NATUS risk results classified as positive result for aneuploidy, negative result for aneuploidy or 'no call.'
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

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

Sponsor

Natera, Inc.

Collaborators

Houston Perinatal Associates
Lyndhurst Clinical Research
Dr. Carpenter Maternal Fetal Medicine Clinic
San Diego Perinatal Center

Investigators

  • Principal Investigator: Brian Kirshon, MD, Houston Perinatal Associates
  • Principal Investigator: Robert Lamar Parker, MD, Lyndhurst Clinical Research
  • Principal Investigator: Robert Carpenter, MD, Office of Dr. Robert Carpenter
  • Principal Investigator: Zach Demko, PhD, Natera, Inc.

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

Helpful Links

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

March 1, 2013

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-016-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.

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