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Observational Study of NIPT in Pregnant Individuals

This study is looking at Non-invasive pregnancy testing (NIPT) in pregnant individuals. NIPT is a test that can screen for certain genetic conditions in a developing baby. The researchers want to understand how well NIPT works in real-world situations and identify factors that might be linked to difficult pregnancy outcomes. You can join if you are pregnant, are 18 or older, and have already had NIPT from Sequenom/Integrated Genetics. The study will consider NIPT's performance as successful if it accurately reflects pregnancy outcomes, measured at 9 months. The current status of this study is unclear, but it plans to include 25,000 participants.

Study design
This is an observational study planning to enroll 25,000 pregnant individuals. It is not a randomized study, meaning participants are not assigned to different treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up for 9 months to measure NIPT clinical outcome performance.

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NCT04595201

Clinical Follow-up of Pregnant Subjects Undergoing NIPT

Recruiting
Not specifiedAges 18+Observational
Sequenom, Inc.
~25,000 participants
Updated 2024-10-16 on ClinicalTrials.gov
What's tested:NIPT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
NIPT clinical outcome performance
Measured over 9 months
+3 more outcomes measured

Conditions

Pregnancy

Explore related trials

Pregnancy

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Kimberly Fanelli, MS, CGC · PRINCIPAL_INVESTIGATOR · Integrated Genetics

Who to contact

Kimberly Fanelli, MS, CGC
[email protected]
603-714-5063
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

None

What this trial measures

  • NIPT clinical outcome performance9 months

    Sensitivity

  • NIPT clinical outcome performance9 months

    Specificity

  • NIPT clinical outcome performance9 months

    Positive predictive value

  • NIPT clinical outcome performance9 months

    Negative predictive value