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NCT04595201 Clinical Trial

Clinical Follow-up of Pregnant Subjects Undergoing NIPT

Pregnancy Clinical Trial

Official title:
Clinical Follow-up of Pregnant Subjects Undergoing NIPT

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04595201
Other study ID # SCMM-RND-111
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 13, 2020
Est. completion date October 13, 2025

Study information
Verified date August 2023
Source Sequenom, Inc.
Contact Kimberly Fanelli, MS, CGC
Phone 603-714-5063
Email kimberly.fanelli@integratedgenetics.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25000
Est. completion date October 13, 2025
Est. primary completion date October 13, 2025
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• NIPT
Non-invasive pregnancy testing

Locations
Country Name City State
United States Integrated Genetics Westborough Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Sequenom, Inc. Integrated Genetics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary NIPT clinical outcome performance Sensitivity 9 months
Primary NIPT clinical outcome performance Specificity 9 months
Primary NIPT clinical outcome performance Positive predictive value 9 months
Primary NIPT clinical outcome performance Negative predictive value 9 months
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