AneuploidyNCT02284399
National Prevalence and Impact of Noninvasive Prenatal Testing
An observational study of Aneuploidy, run by Obstetrix Medical Group at 7 sites in United States.
Trial summary
Information on pregnant women undergoing non-invasive prenatal testing (NIPT) at one of the Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be retrospectively gathered and an analysis of the impact and prevalence of NIPT. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aneuploidy
- What is being tested?
- non-invasive prenatal testing
- How many people
- 4,488 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2014to 1 Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All pregnant women at participating Obstetrix Outpatient centers who are undergoing IDTFK between January 2012 and June 2014.
Who may be able to join
- Pregnant Women
- Presented to a participating Obstetrix Outpatient Center for an invasive prenatal diagnostic testing for fetal karyotype (IDTFK) (i.e. amniocentesis or CVS).
- Invasive prenatal diagnostic testing for fetal karyotype (IDTFK) (i.e. amniocentesis or CVS) performed between January 2012 and June 2014 (A control group enrolled between January 2010 - July 2010)
Who cannot join
- Patient less than 18 years of age
- Patients not receiving a invasive prenatal diagnostic testing for fetal karyotype (IDTFK)(i.e. amniocentesis or CVS) at a participating study center
- Testing NOT done within the window for inclusion (Jan 2012 - June 2014) or Control Group window (January 2010 - July 2010)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Presbyterian/St Luke's Hospital
Denver, Colorado, 80218
Long Beach Memorial Medical Center
Long Beach, California, 90801-1428
Phoenix Perinatal Associates
Phoenix, Arizona, 85014
Maryland Perinatal Associates
Rockville, Maryland, 20850
Good Samaritan Hospital
San Jose, California, 95124
Swedish Medical Center
Seattle, Washington, 98122-4307
Mercy Hospital of St. Louis
St Louis, Missouri, 63141
About this study
Information on pregnant women undergoing non-invasive prenatal testing (NIPT) at one of the Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be retrospectively gathered and an analysis of the impact and prevalence of NIPT. This will be compared to a control group of pregnant women in those same practices undergoing prenatal testing during the months of January 2010-July 2010.
Read the detailed description
Information regarding the frequency of non-invasive testing (NIPT), the impact of screening on the need for and frequency of invasive testing, and the indications for testing are important for the clinicians in this country to not only understand the impact that this testing has had but also to plan for allocation of personnel and resources in their prenatal testing units, as well as many other more subtle changes including describing changes to referring clinicians and patients and projecting financial impacts. Information on pregnant women undergoing NIPT at one of the Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be retrospectively gathered and compared to a control group of pregnant women in those same practices undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK) during the months of January 2010-July 2010. An analysis of the impact of NIPT will be done.
- Conditions
- Aneuploidy
- Being tested
- non-invasive prenatal testing
- Keywords
- aneuploidy, Trisomy 21, NIPT
- Medical subject headings
- Aneuploidy, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive prenatal testingOther
Also called NIPT
Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation
| Study group | Role | What they receive |
|---|---|---|
| IDTFK Group Post NIPT - (January 2012-June 2014) | Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). Receives: Other: non-invasive prenatal testing | |
| IDTFK Group pre-NIPT (January 2010-July 2010) | A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market
Total Number of patient undergoing invasive diagnostic testing for fetal karyotype (IDTFK) before (control group = Jan - July 2010) and after (test group=Jan 2012-June 2014) NIPT testing came to market
Measured: 4 years
Secondary outcomes (1)
Frequency of Positive Tests for Abnormal Karyotype Before and After the Adoption of NIPT Testing.
Will determine if frequency of positive tests for abnormal karyotypes between the control period and the study period where different.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startJan 2014
- Primary completion28 Jun 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AneuploidyStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrix Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly Maurel, MSN, Study director, Mednax Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284399
- Sponsor's protocol ID
- OBX0032
- Status last verified
- Mar 2019
- First submitted
- 21 Oct 2014
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Prevalence and Impact of Noninvasive Prenatal Testing
- ClinicalTrials.gov ID
- NCT02284399
- Acronym / sponsor ID
- OBX0032
- Conditions
- Aneuploidy
- Keywords
- aneuploidy, Trisomy 21, NIPT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,488 participants (actual)
- Lead sponsor
- Obstetrix Medical GroupIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- 28 Jun 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Information on pregnant women undergoing non-invasive prenatal testing (NIPT) at one of the Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be retrospectively gathered and an analysis of the impact and prevalence of NIPT. This will be compared to a control group of pregnant women in those same practices undergoing prenatal testing during the months of January 2010-July 2010.
Detailed description
Information regarding the frequency of non-invasive testing (NIPT), the impact of screening on the need for and frequency of invasive testing, and the indications for testing are important for the clinicians in this country to not only understand the impact that this testing has had but also to plan for allocation of personnel and resources in their prenatal testing units, as well as many other more subtle changes including describing changes to referring clinicians and patients and projecting financial impacts. Information on pregnant women undergoing NIPT at one of the Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be retrospectively gathered and compared to a control group of pregnant women in those same practices undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK) during the months of January 2010-July 2010. An analysis of the impact of NIPT will be done.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDTFK Group Post NIPT - (January 2012-June 2014) | – | Other: non-invasive prenatal testingPregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). |
| IDTFK Group pre-NIPT (January 2010-July 2010) | – | –A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pregnant women at participating Obstetrix Outpatient centers who are undergoing IDTFK between January 2012 and June 2014.
Key inclusion criteria (3 listed)
- Pregnant Women
- Presented to a participating Obstetrix Outpatient Center for an invasive prenatal diagnostic testing for fetal karyotype (IDTFK) (i.e. amniocentesis or CVS).
- Invasive prenatal diagnostic testing for fetal karyotype (IDTFK) (i.e. amniocentesis or CVS) performed between January 2012 and June 2014 (A control group enrolled between January 2010 - July 2010)
Key exclusion criteria (3 listed)
- Patient less than 18 years of age
- Patients not receiving a invasive prenatal diagnostic testing for fetal karyotype (IDTFK)(i.e. amniocentesis or CVS) at a participating study center
- Testing NOT done within the window for inclusion (Jan 2012 - June 2014) or Control Group window (January 2010 - July 2010)
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 |
|---|---|---|
| non-invasive prenatal testingAlso: NIPTNoninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation | Other | IDTFK Group Post NIPT - (January 2012-June 2014) |
Primary outcome
Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market
Time frame: 4 years
Total Number of patient undergoing invasive diagnostic testing for fetal karyotype (IDTFK) before (control group = Jan - July 2010) and after (test group=Jan 2012-June 2014) NIPT testing came to market
1 secondary outcome
Frequency of Positive Tests for Abnormal Karyotype Before and After the Adoption of NIPT Testing.
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 Maurel, MSN study director
Mednax Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneuploidy, run by Obstetrix Medical Group at 7 sites 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 3 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market (time frame: 4 years). 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 19 Jun 2019.