Clinical trial NCT02284399: National Prevalence and Impact of Noninvasive Prenatal Testing
Official title: National Prevalence and Impact of Noninvasive Prenatal Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneuploidy
Keywords: aneuploidy
Trisomy 21
NIPT
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 4488
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market
timeFrame: 4 years
Secondary outcomes:
measure: Frequency of Positive Tests for Abnormal Karyotype Before and After the Adoption of NIPT Testing.
timeFrame: 4 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Perinatal Associates
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Denver
country: United States
facility: Presbyterian/St Luke's Hospital
state: Colorado
city: Rockville
country: United States
facility: Maryland Perinatal Associates
state: Maryland
city: Saint Louis
country: United States
facility: Mercy Hospital of St. Louis
state: Missouri
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Mednax Inc.
name: Kimberly Maurel, MSN
role: STUDY_DIRECTOR
References: