Clinical Follow-up of Pregnant Subjects Undergoing NIPT

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04595201

Enrollment

20000

Registered

2020-10-20

Start date

2020-10-13

Completion date

2026-09-02

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Brief summary

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

Interventions

DEVICENIPT

Non-invasive pregnancy testing

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
NIPT clinical outcome performance	9 months	Sensitivity

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKimberly Fanelli, MS, CGC

Integrated Genetics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026