National Prevalence and Impact of Noninvasive Prenatal Testing

Aneuploidy Clinical Trial

Official title:

National Prevalence and Impact of Noninvasive Prenatal Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284399
• Other study ID #: OBX0032
• Status: Completed
• Start date: January 2014
• Est. completion date: December 1, 2016

Study information

• Verified date: March 2019
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 4488
• Est. completion date: December 1, 2016
• Est. primary completion date: June 28, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

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)

Related Conditions & MeSH terms

• Aneuploidy

Intervention

Other:
• non-invasive prenatal testing
Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation

Locations

Country	Name	City	State
United States	Presbyterian/St Luke's Hospital	Denver	Colorado
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Phoenix Perinatal Associates	Phoenix	Arizona
United States	Maryland Perinatal Associates	Rockville	Maryland
United States	Mercy Hospital of St. Louis	Saint Louis	Missouri
United States	Good Samaritan Hospital	San Jose	California
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Obstetrix Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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