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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDTFK Group Post NIPT - (January 2012-June 2014) | Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). |
| |
| IDTFK Group pre-NIPT (January 2010-July 2010) | A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive prenatal testing | Other | Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All pregnant women at participating Obstetrix Outpatient centers who are undergoing IDTFK between January 2012 and June 2014.
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Maurel, MSN | Mednax Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Perinatal Associates | Phoenix | Arizona | 85014 | United States | ||
| Long Beach Memorial Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | IDTFK Group Pre-NIPT (January 2010-July 2010) | A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).
|
| FG001 | IDTFK Group Post NIPT - (January 2012-June 2014) | Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IDTFK Group Post NIPT - (January 2012-June 2014) | Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). |
| BG001 | IDTFK Group Pre-NIPT (January 2010-July 2010) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | This was an observational study that looked to compare the number of patient who underwent IDTFK during Jan 2010-July 2010 (prior to the adoption of NIPT) with the number of patients who underwent IDTFK during Jan 2012-June 2014 (after the adoption of NIPT). | Posted | Count of Participants | Participants | 4 years |
|
This was an retrospective study. Adverse events were not captured
This was an retrospective study. Adverse events were not captured
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDTFK Group Pre-NIPT (January 2010-July 2010) | A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Maurel | Mednax. Inc | 714-593-9171 | kimberly_maurel@mednax.com |
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| ID | Term |
|---|---|
| D000782 | Aneuploidy |
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008607 | Intellectual Disability |
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| ID | Term |
|---|---|
| C042494 | dichlorobis(azomycin)platinum II |
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|
| Long Beach |
| California |
| 90801-1428 |
| United States |
| Good Samaritan Hospital | San Jose | California | 95124 | United States |
| Presbyterian/St Luke's Hospital | Denver | Colorado | 80218 | United States |
| Maryland Perinatal Associates | Rockville | Maryland | 20850 | United States |
| Mercy Hospital of St. Louis | St Louis | Missouri | 63141 | United States |
| Swedish Medical Center | Seattle | Washington | 98122-4307 | United States |
A control group of pregnant women, prior to the release of non-invasive prenatal testing (NIPT), who present to participating centers between January 2010-June 2010 and are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Indication for invasive test was Advance Maternal Age (AMA) | Count of Participants | Participants |
|
| Indication for invasive test was Family History of Aneuploidy | Count of Participants | Participants |
|
| Indication for invasive test was a Positive Serum Screening Test | Count of Participants | Participants |
|
| Indication for invasive test was Ultrasound Abnormality noted | Count of Participants | Participants |
|
| Indication for and invasive test was a Positive cell free DNA (cfDNA) | Count of Participants | Participants |
|
| Karyotype Results of Amniocentesis and CVS - Normal Result | Note: percentages sum to more than 100% because some patient had more than one indication. | Note: percentages sum to more than 100% because some patient had more than one indication. | Number | indications |
|
| Indication for an invasive test was multifetal gestation | Count of Participants | Participants |
|
| OG001 | IDTFK Group Post NIPT - (January 2012-June 2014) | Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK). non-invasive prenatal testing: Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation |
|
|
| 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. | The number of positive tests identified between the control and the test periods. | Posted | Count of Participants | Participants | 4 years |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | IDTFK Group Post NIPT - (January 2012-June 2014) | Pregnant women who present to participating centers between January 2012-June 2014, after the release of non-invasive prenatal testing (NIPT), who are undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK).
| 0 | 0 | 0 | 0 | 0 | 0 |
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| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |