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OpenTrials
Completed

NCT Number: NCT04595201

Clinical Follow-up of Pregnant Subjects Undergoing NIPT

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

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Integrated Genetics

Westborough, Massachusetts, 01581, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIPT

Device

Non-invasive pregnancy testing

Primary outcomes

  1. NIPT clinical outcome performance

    Time frame: 9 months

    Sensitivity

  2. NIPT clinical outcome performance

    Time frame: 9 months

    Specificity

  3. NIPT clinical outcome performance

    Time frame: 9 months

    Positive predictive value

  4. NIPT clinical outcome performance

    Time frame: 9 months

    Negative predictive value

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Collaborators

  • Integrated Genetics

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2020
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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