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Recruiting NCT04595201

Clinical Follow-up of Pregnant Subjects Undergoing NIPT

— Observational Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NIPT.
Who it may be relevant to
Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device NIPT
    Non-invasive pregnancy testing

Primary outcome measures

  • NIPT clinical outcome performance [Time frame: 9 months]
  • NIPT clinical outcome performance [Time frame: 9 months]
  • NIPT clinical outcome performance [Time frame: 9 months]
  • NIPT clinical outcome performance [Time frame: 9 months]

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

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Integrated Genetics — Westborough

Identifiers

NCT: NCT04595201 · SCMM-RND-111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗