Clinical Trial: National Prevalence and Impact of Noninvasive Prenatal Testing

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: National Prevalence and Impact of Noninvasive Prenatal Testing

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 Summary: 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 prenatal testing during the months of January 2010-July 2010. An analysis of the impact of NIPT will be done.
Sponsor: Obstetrix Medical Group

Current Primary Outcome: The number of invasive prenatal diagnostic testing for fetal karyotype (IDTFKs) performed after NIPT became commercially available [ Time Frame: 4 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The reasons for invasive prenatal diagnostic testing for fetal karyotype (IDTFK) after NIPT became commercially available [ Time Frame: 4 years ]

Will determine if the actual reason or indications for invasive testing has changed after NIPT became available.


Original Secondary Outcome: Same as current

Information By: Mednax Center for Research, Education and Quality

Dates:
Date Received: October 21, 2014
Date Started: January 2014
Date Completion: September 2016
Last Updated: March 11, 2016
Last Verified: March 2016