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National Prevalence and Impact of Noninvasive Prenatal Testing

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ClinicalTrials.gov Identifier: NCT02284399
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety ( Obstetrix Medical Group )

Brief 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. 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.

Condition or disease Intervention/treatment
Aneuploidy Other: non-invasive prenatal testing

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 prenatal testing during the months of January 2010-July 2010. An analysis of the impact of NIPT will be done.

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Study Type : Observational
Actual Enrollment : 4382 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: National Prevalence and Impact of Noninvasive Prenatal Testing
Study Start Date : January 2014
Actual Primary Completion Date : June 28, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
Other: non-invasive prenatal testing
Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation
Other Name: NIPT

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).



Primary Outcome Measures :
  1. The number of invasive prenatal diagnostic testing for fetal karyotype (IDTFKs) performed after NIPT became commercially available [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. The reasons for invasive prenatal diagnostic testing for fetal karyotype (IDTFK) after NIPT became commercially available [ Time Frame: 4 years ]
    Will determine if the actual reason or indications for invasive testing has changed after NIPT became available.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All pregnant women at participating Obstetrix Outpatient centers who are undergoing IDTFK between January 2012 and June 2014.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284399


Locations
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United States, Arizona
Phoenix Perinatal Associates
Phoenix, Arizona, United States, 85014
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90801-1428
Good Samaritan Hospital
San Jose, California, United States, 95124
United States, Colorado
Presbyterian/St Luke's Hospital
Denver, Colorado, United States, 80218
United States, Maryland
Maryland Perinatal Associates
Rockville, Maryland, United States, 20850
United States, Missouri
Mercy Hospital of St. Louis
Saint Louis, Missouri, United States, 63141
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122-4307
Sponsors and Collaborators
Obstetrix Medical Group
Investigators
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Study Director: Kimberly Maurel, MSN Mednax Inc.

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Responsible Party: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT02284399     History of Changes
Other Study ID Numbers: OBX0032
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mednax Center for Research, Education, Quality and Safety ( Obstetrix Medical Group ):
aneuploidy
Trisomy 21
NIPT

Additional relevant MeSH terms:
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Aneuploidy
Chromosome Aberrations
Pathologic Processes