National Prevalence and Impact of Noninvasive Prenatal Testing

Completed

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.

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
IDTFK Group Post NIPT - (January 2012-June 2014)	non-invasive prenatal testing	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).

Primary Outcome Measures

Name	Time	Method
Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market	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

Secondary Outcome Measures

Name	Time	Method
Frequency of Positive Tests for Abnormal Karyotype Before and After the Adoption of NIPT Testing.	4 years	Will determine if frequency of positive tests for abnormal karyotypes between the control period and the study period where different.

Locations (7): Good Samaritan Hospital
🇺🇸
San Jose, California, United States
Presbyterian/St Luke's Hospital
🇺🇸
Denver, Colorado, United States
Mercy Hospital of St. Louis
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Saint Louis, Missouri, United States
Swedish Medical Center
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Seattle, Washington, United States
Long Beach Memorial Medical Center
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Long Beach, California, United States
Maryland Perinatal Associates
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Rockville, Maryland, United States
Phoenix Perinatal Associates
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Phoenix, Arizona, United States