National Prevalence and Impact of Noninvasive Prenatal Testing

NCT02284399 | Completed Results

• 1 other identifier: OBX0032
• Study Type: observational
• Target: 4,488
• Locations: 1 country
• Sites: 7

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.

Conditions

Aneuploidy

Keywords

aneuploidy; Trisomy 21; NIPT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of Positive Tests for Abnormal Karyotype Before and After the Adoption of NIPT Testing.

  4 years

Study Arms (2)

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

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).

Interventions

non-invasive prenatal testing OTHER

Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation

Also known as: NIPT

IDTFK Group Post NIPT - (January 2012-June 2014)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Obstetrix Medical Group: lead

Study Sites (7)

Phoenix Perinatal Associates

Phoenix, Arizona, 85014, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90801-1428, United States

Location

Good Samaritan Hospital

San Jose, California, 95124, United States

Location

Presbyterian/St Luke's Hospital

Denver, Colorado, 80218, United States

Location

Maryland Perinatal Associates

Rockville, Maryland, 20850, United States

Location

Mercy Hospital of St. Louis

St Louis, Missouri, 63141, United States

Location

Swedish Medical Center

Seattle, Washington, 98122-4307, United States

Location

MeSH Terms

Conditions

Aneuploidy; Down Syndrome

Interventions

dichlorobis(azomycin)platinum II

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Results Point of Contact

• Title: Kimberly Maurel
• Organization: Mednax. Inc

kimberly_maurel@mednax.com

714-593-9171

Study Officials

• Kimberly Maurel, MSN

  Mednax Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 6, 2014
• Study Start: January 1, 2014
• Primary Completion: June 28, 2016
• Study Completion: December 1, 2016
• Last Updated: June 19, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-03

Locations

US (7)