Clinical Follow-up of Pregnant Subjects Undergoing NIPT

August 7, 2023 updated by: Sequenom, Inc.
To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT) to analyze the performance of routine assay enhancements and to identify characteristics associated with adverse obstetric outcome.

Study Type

Observational

Enrollment (Estimated)

25000

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Westborough, Massachusetts, United States, 01581
        • Recruiting
        • Integrated Genetics
        • Contact:
          • Kimberly Fanelli, MS, CGC

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

N/A

Sampling Method

Non-Probability Sample

Study Population

The Study Population will consist of women 18 years of age and older who underwent testing with a Sequenom NIPT and whose pregnancies should have outcome based upon gestational age at the time of testing.

Description

Inclusion Criteria:

  • Subject was pregnant and received NIPT from Sequenom/Integrated Genetics
  • Subject was 18 years of age or older at the time of NIPT
  • Pregnancy outcome is available

Exclusion Criteria:

  • None

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
Measure Description
Time Frame
NIPT clinical outcome performance
Time Frame: 9 months
Sensitivity
9 months
NIPT clinical outcome performance
Time Frame: 9 months
Specificity
9 months
NIPT clinical outcome performance
Time Frame: 9 months
Positive predictive value
9 months
NIPT clinical outcome performance
Time Frame: 9 months
Negative predictive value
9 months

Collaborators and Investigators

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

Sponsor

Sequenom, Inc.

Collaborators

Integrated Genetics

Investigators

  • Principal Investigator: Kimberly Fanelli, MS, CGC, Integrated Genetics

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 (Actual)

October 13, 2020

Primary Completion (Estimated)

October 13, 2025

Study Completion (Estimated)

October 13, 2025

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SCMM-RND-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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