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Clinical Trials/NCT04595201
NCT04595201
Recruiting
Not Applicable

Clinical Follow-up of Pregnant Subjects Undergoing NIPT

Sequenom, Inc.1 site in 1 country25,000 target enrollmentOctober 13, 2020
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ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Sequenom, Inc.
Enrollment
25000
Locations
1
Primary Endpoint
NIPT clinical outcome performance
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 13, 2020
End Date
October 13, 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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

  • Not provided

Outcomes

Primary Outcomes

NIPT clinical outcome performance

Time Frame: 9 months

Negative predictive value

Study Sites (1)

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