Development of a Non-invasive Prenatal Test

April 28, 2020 updated by: Cindy Cisneros
This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

Study Overview

Status

Completed

Conditions

Detailed Description

Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.

Study Type

Observational

Enrollment (Actual)

15000

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
    • California
      • San Jose, California, United States, 95138
        • Ariosa Diagnostics

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

Female

Sampling Method

Non-Probability Sample

Study Population

This study will include women who have a healthy pregnancy.

Description

Inclusion Criteria:

  • Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider
  • Subject is able to provide informed consent
  • Subject is ≥ 18 years of age
  • Subject is at least 10 weeks gestation for general enrollment
  • Subject has no known risk factors for chromosomal abnormalities of the fetus
  • Subject has no suspected or confirmed fetal abnormalities

Exclusion Criteria:

  • Subject is pregnant with more than two fetuses
  • Subject is unwilling to undergo a blood draw

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of chromosomal abnormality
Time Frame: At time of enrollment
At time of enrollment

Collaborators and Investigators

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

Sponsor

Cindy Cisneros

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

June 1, 2011

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (ESTIMATE)

October 14, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TD003

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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