Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Follow-up of Pregnant Subjects Undergoing NIPT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04595201
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Integrated Genetics
Information provided by (Responsible Party):
Sequenom, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).

Condition or disease Intervention/treatment
Pregnancy Device: NIPT

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Follow-up of Pregnant Subjects Undergoing NIPT
Actual Study Start Date : October 13, 2020
Estimated Primary Completion Date : October 13, 2025
Estimated Study Completion Date : October 13, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: NIPT
    Non-invasive pregnancy testing

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. NIPT clinical outcome performance [ Time Frame: 9 months ]
    Sensitivity

  2. NIPT clinical outcome performance [ Time Frame: 9 months ]
    Specificity

  3. NIPT clinical outcome performance [ Time Frame: 9 months ]
    Positive predictive value

  4. NIPT clinical outcome performance [ Time Frame: 9 months ]
    Negative predictive value


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Follow-up of pregnant subjects who have undergone NIPT
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595201


Contacts
Layout table for location contacts
Contact: Kimberly Fanelli, MS, CGC 603-714-5063 kimberly.fanelli@integratedgenetics.com

Locations
Layout table for location information
United States, Massachusetts
Integrated Genetics Recruiting
Westborough, Massachusetts, United States, 01581
Contact: Kimberly Fanelli, MS, CGC         
Sponsors and Collaborators
Sequenom, Inc.
Integrated Genetics
Investigators
Layout table for investigator information
Principal Investigator: Kimberly Fanelli, MS, CGC Integrated Genetics
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT04595201    
Other Study ID Numbers: SCMM-RND-111
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No