Skip to main content
OpenTrials
Recruiting

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).

Recruiting

Interested in participating?

Request Info

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

Location status: Recruiting

Location contact

Kimberly Fanelli, MS, CGC

CONTACT

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

Healthy volunteers accepted: No

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Fanelli, MS, CGC

CONTACT

[email protected]

603-714-5063

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Collaborators

  • Integrated Genetics

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 20, 2020
Registry last updated
Oct 16, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.