NCT04595201

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2025

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

5 years

First QC Date

October 14, 2020

Last Update Submit

October 11, 2024

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (4)

  • NIPT clinical outcome performance

    Sensitivity

    9 months

  • NIPT clinical outcome performance

    Specificity

    9 months

  • NIPT clinical outcome performance

    Positive predictive value

    9 months

  • NIPT clinical outcome performance

    Negative predictive value

    9 months

Interventions

NIPTDEVICE

Non-invasive pregnancy testing

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFollow-up of pregnant subjects who have undergone NIPT
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Study Population will consist of women 18 years of age and older who underwent testing with a Sequenom NIPT and whose pregnancies should have outcome based upon gestational age at the time of testing.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Genetics

Westborough, Massachusetts, 01581, United States

RECRUITING

Study Officials

  • Kimberly Fanelli, MS, CGC

    Integrated Genetics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Fanelli, MS, CGC

CONTACT

603-714-5063kimberly.fanelli@integratedgenetics.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 20, 2020

Study Start

October 13, 2020

Primary Completion

October 13, 2025

Study Completion

October 13, 2025

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)