NCT04774640

Brief Summary

To collect whole blood samples from pregnant women for the purpose of developing, optimizing and evaluating laboratory-developed noninvasive prenatal test (NIPT) for the detection of fetal chromosomal abnormalities of interest defined as microinsertions, microdeletions and other copy number variations (CNVs). The NIPT result will be compared to the test results obtained by microarray analysis of fetal cellular material obtained by amniocentesis or chorionic villus sampling.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Last Updated

August 9, 2023

Status Verified

February 1, 2021

Enrollment Period

3.9 years

First QC Date

February 25, 2021

Last Update Submit

August 7, 2023

Conditions

Copy Number Variations

Outcome Measures

Primary Outcomes (1)

  • Development of non-invasive pregnancy test (NIPT)

    NIPT results will be compared to test results obtain by microarray analysis of fetal cellular material obtained by amniocentesis or chorionic villus sampling

    5 years

Interventions

MaterniT GENOMEDEVICE

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSubjects must be pregnant
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with a fetus previously determined by microarray to have a chromosomal abnormality of interest..

You may qualify if:

  • Subject is female
  • Subject is 18 years of age or older
  • Subject is pregnant at no less than 10 weeks and no more than 36 weeks gestation
  • Subject provides a signed and dated informed consent
  • Subject has a current pregnancy in which the fetus is determined to have a chormosomal abnormality of interest (microinsertions, microdeletions and other CNVs) as determined by microarray analysis of fetal cellular material obtained by IP

You may not qualify if:

  • Subject has experienced fetal demise in the current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal plasma with cell free fetal DNA

Study Design

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

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

May 29, 2014

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

August 9, 2023

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)