Noninvasive Prenatal Testing
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 14 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | September 2015 |
| End Date: | May 2017 |
| Contact: | Judy A Thompson, RN |
| Email: | jathompson@slu.edu |
| Phone: | 977-2090 |
Decision-Making in Patients Regarding Noninvasive Prenatal Testing
Before and after a patient receives genetic counseling they will be offered the chance to
complete the survey, by their counselor. Since each patient sees only one genetic counselor
that counselor will be responsible for consenting and giving and collecting the finish
surveys. No identifiers will be used. The investigators will emphasize that their answers
will remain anonymous throughout the entire process, and that their participation is
strictly voluntary. The patient will be provided with a survey and asked to complete this
before their genetic counseling session and after.The survey will be returned to the genetic
counselor and placed in a locked drawer. Information will also be collected from the medical
record including age, pregnancy history and the reason for the visit.
complete the survey, by their counselor. Since each patient sees only one genetic counselor
that counselor will be responsible for consenting and giving and collecting the finish
surveys. No identifiers will be used. The investigators will emphasize that their answers
will remain anonymous throughout the entire process, and that their participation is
strictly voluntary. The patient will be provided with a survey and asked to complete this
before their genetic counseling session and after.The survey will be returned to the genetic
counselor and placed in a locked drawer. Information will also be collected from the medical
record including age, pregnancy history and the reason for the visit.
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.
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.
Inclusion Criteria:
- high risk pregnant women seen for genetic counseling
Exclusion Criteria:
- low risk
- not pregnant
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