Clinical Follow-up of Pregnant Subjects Undergoing NIPT

Recruiting

• Conditions: Pregnancy

• Registration Number: NCT04595201
• Lead Sponsor: Sequenom, Inc.

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.

Study Timeline

• Study Start: 2020-10-13
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-10-13
• Study Completion: 2025-10-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NIPT clinical outcome performance	9 months	Negative predictive value

Trial Locations

Locations (1)

Integrated Genetics; 🇺🇸 Westborough, Massachusetts, United States