- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02586428
Noninvasive Prenatal Testing
Decision-Making in Patients Regarding Noninvasive Prenatal Testing
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients who have abnormal ultrasound findings,advanced maternal age, abnormal serum biochemical screening, or a personal or family history of chromosomal/genetic conditions will be eligible for this study. Prior to receiving genetic counseling, the genetic counselor or her designee will approach the patient asking if she would be willing to participate in a survey that helps us better determine how well patients understand their testing options for the above issues.
The survey consists of two parts. The first part will be taken prior to genetic counseling to see what the patient's baseline understanding of their options are (this is study related.) If the patient agrees to participate in the study, she will then receive the first part of the survey. After completion of the first part of the survey, the patient will then receive genetic counseling (this is standard of care.). Information will also be collected from the medical record including age, pregnancy history and the reason for the visit. After receiving genetic counseling for their specific indication, patients will decide if they want noninvasive prenatal testing, amniocentesis, testing depending what their ultrasound shows, or no testing. After this the patient will be given the second part of the survey to complete (this is study related). Regardless of which testing is elected, (if any), participants are administered the same survey. After completing the survey, the patient will return the form to the genetic counselor or her designee. The recruitment period is expected to last approximately one year. After recruitment is completed, data analysis will take place. Interim data analysis make take place as well.
Patients will not be contacted for research purposes after the survey has been completed.
After patients complete this survey, they will require no further information. They are not being administered a treatment or receiving a direct benefit from participation; the study is designed only to obtain information about patient's decisions, knowledge, and attitudes regarding their testing options.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Missouri
-
St. Louis,, Missouri, United States, 63117
- St. Mary's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- high risk pregnant women seen for genetic counseling
Exclusion Criteria:
- low risk
- not pregnant
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
will measure what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling
Time Frame: over the next 6 months
|
percentages of patient's choices
|
over the next 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
will measure patients' reasons for electing or not electing testing
Time Frame: over the next 6 months
|
Reasons for not electing to have testing
|
over the next 6 months
|
Measure if patients' understand the different testing options.
Time Frame: over next 6 months
|
Are they able to give explanation of testing
|
over next 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gary Fruhman, MD, St. Louis University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 25878
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Genetic Counseling
-
University of California, San FranciscoNational Cancer Institute (NCI); National Institutes of Health (NIH); University...CompletedGenetic CounselingUnited States
-
National Human Genome Research Institute (NHGRI)Completed
-
National Human Genome Research Institute (NHGRI)CompletedGenetic Counseling | AdoptionUnited States
-
Instituto Nacional de Ciencias Medicas y Nutricion...CompletedHereditary Cancer | Genetic CounselingMexico
-
Hospital Clinic of BarcelonaCompletedGenetic Counseling | Prenatal DiagnosisSpain
-
National Human Genome Research Institute (NHGRI)CompletedGenetic Counseling | Moral Value Conflicts | Moral DistressUnited States
-
Erin RothwellNational Human Genome Research Institute (NHGRI)RecruitingPregnancy | Shared Decision Making | Genetic Testing | Genetic Counseling | Prenatal DisorderUnited States
-
Stanford UniversityCompletedGenetic Counseling ProfessionUnited States
-
Central Hospital, Nancy, FranceCompletedGenetic Disease | CNV | Genetic Counseling | Array CGHFrance
-
Hospital Universitario La FeUnknownCancer | Psychological Distress | Hereditary Diseases | Genetic CounselingSpain
Clinical Trials on what patients elect noninvasive prenatal testing (NIPT)
-
Obstetrix Medical GroupCompleted
-
CHU de Quebec-Universite LavalUniversity of British Columbia; McGill University; Canadian Institutes of Health... and other collaboratorsActive, not recruitingAneuploidy | Prenatal DisorderCanada
-
CHU de Quebec-Universite LavalCanadian Institutes of Health Research (CIHR); Laval University; Genome British... and other collaboratorsCompletedTrisomy 21 | Trisomy 18 | Trisomy 13Canada