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CompletedNCT04595201Updated Sep 8, 2026

Clinical Follow-up of Pregnant Subjects Undergoing NIPT

An observational study in Pregnancy, sponsored by Sequenom, Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Sequenom, Inc. (part of Labcorp) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Pregnancy
03

In context

Lead sponsor

Sequenom, Inc. is the lead sponsor of 26 studies on the registry; 5 are open to participants now.

First submitted after Sequenom, Inc. became part of Labcorp.

Browse Sequenom, Inc. studies →All Labcorp studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (actual)
Patient registry
No

Interventions

  • DeviceNIPT

    Non-invasive pregnancy testing

06

What researchers measure

Primary outcomes

  1. NIPT clinical outcome performance

    Sensitivity

    Time frame: 9 months

  2. NIPT clinical outcome performance

    Specificity

    Time frame: 9 months

  3. NIPT clinical outcome performance

    Positive predictive value

    Time frame: 9 months

  4. NIPT clinical outcome performance

    Negative predictive value

    Time frame: 9 months

07

Study locations

1 site
  • Integrated Genetics
    Westborough, Massachusetts 01581, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2020 to primary completion in Sep 2026, 70 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2020
First posted
Oct 20, 2020
StartActual
Oct 13, 2020
Primary completionActual
Sep 1, 2026
CompletionActual
Sep 2, 2026
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04595201
Lead sponsor
Sequenom, Inc.
Collaborators
Integrated Genetics
Responsible party
Sponsor
First posted
Oct 20, 2020
Start date
Oct 13, 2020
Primary completion
Sep 1, 2026
Completion
Sep 2, 2026
Last update
Sep 8, 2026

Study contacts

Kimberly Fanelli, MS, CGC
principal investigator · Integrated Genetics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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