Clinical Follow-up of Pregnant Subjects Undergoing NIPT

NCT04595201 — Completed, 20000 participants, Sequenom, Inc.

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Registry	NCT04595201
Status	Completed
Study type	Observational
Enrollment	20000 (Actual)
Sponsor	Sequenom, Inc. (Industry); collaborators: Integrated Genetics
Conditions	Pregnancy
Interventions	NIPT (Device)
Dates	start 2020-10-13, primary completion 2026-09-01, completion 2026-09-02, first posted 2020-10-20, last updated 2026-09-08
Locations	1 site in United States

-Summary

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

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+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.

+Arms and interventions

NIPT (Device): Non-invasive pregnancy testing

+Outcome measures

Primary outcomes

NIPT clinical outcome performance [9 months]: Sensitivity
NIPT clinical outcome performance [9 months]: Specificity
NIPT clinical outcome performance [9 months]: Positive predictive value
NIPT clinical outcome performance [9 months]: Negative predictive value

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Integrated Genetics	Westborough, Massachusetts	United States

+Investigators

Kimberly Fanelli, MS, CGC, Principal investigator, Integrated Genetics

My Notes

Public

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