National Prevalence and Impact of Noninvasive Prenatal Testing

Obstetrix Medical Group4,488 enrolled

Overview

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.

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

4,488

Conditions

Aneuploidy

Interventions

non-invasive prenatal testingOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (7)

Phoenix Perinatal Associates

Phoenix, Arizona, United States

Long Beach Memorial Medical Center

Long Beach, California, United States

Good Samaritan Hospital

San Jose, California, United States

Presbyterian/St Luke's Hospital

Denver, Colorado, United States

Outcomes

Primary Outcomes

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

Time frame: 4 years

Secondary Outcomes

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.

Time frame: 4 years

Data from ClinicalTrials.gov

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