PregnancyNCT04595201
Clinical Follow-up of Pregnant Subjects Undergoing NIPT
An observational study of Pregnancy, run by Sequenom, Inc. at 1 site in United States.
Trial summary
To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- NIPT
- Type of treatment
- Medical device
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to 2 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrated Genetics
Westborough, Massachusetts, 01581
About this study
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.
- Conditions
- Pregnancy
- Being tested
- NIPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPTDevice
Non-invasive pregnancy testing
What is being measured
The primary outcome is the main question the study is designed to answer.
NIPT clinical outcome performance
Sensitivity
Measured: 9 months
NIPT clinical outcome performance
Specificity
Measured: 9 months
NIPT clinical outcome performance
Positive predictive value
Measured: 9 months
NIPT clinical outcome performance
Negative predictive value
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start13 Oct 2020
- Primary completion1 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrated Genetics
- Responsible party
- Sponsor
- Investigators
- Kimberly Fanelli, MS, CGC, Principal investigator, Integrated Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595201
- Sponsor's protocol ID
- SCMM-RND-111
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Follow-up of Pregnant Subjects Undergoing NIPT
- ClinicalTrials.gov ID
- NCT04595201
- Acronym / sponsor ID
- SCMM-RND-111
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Integrated Genetics
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To obtain pregnancy outcome data from patients screened for fetal genetic status using non-invasive pregnancy testing (NIPT).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIPTNon-invasive pregnancy testing | Device | – |
Primary outcome
NIPT clinical outcome performance
Time frame: 9 months
Sensitivity
NIPT clinical outcome performance
Time frame: 9 months
Specificity
NIPT clinical outcome performance
Time frame: 9 months
Positive predictive value
NIPT clinical outcome performance
Time frame: 9 months
Negative predictive value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Fanelli, MS, CGC principal investigator
Integrated Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Sequenom, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIPT clinical outcome performance (time frame: 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.