N/A
N=4,488
National Prevalence and Impact of Noninvasive Prenatal Testing
Aneuploidy
Bottom Line
View on ClinicalTrials.gov: NCT02284399 ↗Enrolled (actual)
4,488
Serious AEs
—
Results posted
Jun 2019
Primary outcome: Primary: Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market — 1414; 3074 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- non-invasive prenatal testing (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Obstetrix Medical Group
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market |
1414; 3074 | — |
| SECONDARY Frequency of Positive Tests for Abnormal Karyotype Before and After the Adoption of NIPT Testing. |
454; 104 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT02284399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.