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OpenTrials
Completed

NCT Number: NCT02284399

National Prevalence and Impact of Noninvasive Prenatal Testing

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Phoenix Perinatal Associates, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

non-invasive prenatal testing

Other

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

Other names: NIPT

Primary outcomes

  1. Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market

    Time frame: 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 outcomes

  1. Frequency of Positive Tests for Abnormal Karyotype Before and After the Adoption of NIPT Testing.

    Time frame: 4 years

    Will determine if frequency of positive tests for abnormal karyotypes between the control period and the study period where different.

Sponsors and collaborators

Lead sponsor

Obstetrix Medical Group

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2014
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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