National Prevalence and Impact of Noninvasive Prenatal Testing

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.

Study Overview

• Status: Completed
• Conditions: Aneuploidy
• Intervention / Treatment: 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 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 Type: Observational
• Enrollment (Actual): 4488

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85014
      • Phoenix Perinatal Associates
  • California
    • Long Beach, California, United States, 90801-1428
      • Long Beach Memorial Medical Center
    • San Jose, California, United States, 95124
      • Good Samaritan Hospital
  • Colorado
    • Denver, Colorado, United States, 80218
      • Presbyterian/St Luke's Hospital
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Maryland Perinatal Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital of St. Louis
  • Washington
    • Seattle, Washington, United States, 98122-4307
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years

Collaborators and Investigators

• Sponsor: Obstetrix Medical Group
• Investigators: Study Director: Kimberly Maurel, MSN, Mednax Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 28, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: aneuploidy; Trisomy 21; NIPT
• Additional Relevant MeSH Terms: Pathologic Processes; Chromosome Aberrations; Aneuploidy
• Other Study ID Numbers: OBX0032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED