Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342069
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Prevalence of Ambivalence Regarding Prenatal Testing
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Facilitating Informed for Prenatal Testing The Role of Ambivalence
Status:
COMPLETED
Status Verified Date:
2007-12-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine how women think and feel about prenatal testing amniocentesis and chorionic villus sampling how those thoughts and feelings change over time and how they contribute to the decision whether or not to undergo prenatal testing
Prenatal diagnostic testing is offered to pregnant women at increased risk of carrying a baby affected with a genetic or chromosomal abnormality Although these tests are well established standard-of-care procedures much remains unknown about how best to ensure that women make decisions about whether or not to undergo testing that are consistent with their beliefs and values This study will explore the extent to which women are ambivalent about prenatal testing and determine how they might benefit from counseling aimed at improving the quality of their decision-making
Women 18 years of age and older who are scheduled for a prenatal genetics visit at clinics in Baltimore MD Minneapolis MN Binghamton NY Salt Lake City UT Washington DC and Bellevue WA and are at increased risk for having a baby with trisomy 21 Down syndrome may be eligible for this study
Participants complete two short questionnaires and a telephone interview about their thoughts and feelings regarding prenatal testing The first two surveys examine the womens thoughts and feelings before and after prenatal counseling Both are completed at the prenatal clinic-one before and one after the counseling session The third survey is done by telephone a few weeks after the prenatal visit to find out if the participant did or did not have prenatal testing and learn about her thoughts and feelings regarding her decision
Prenatal diagnostic testing is offered to pregnant women at increased risk of carrying a baby affected with a genetic or chromosomal abnormality Although these tests are well established standard-of-care procedures much remains unknown about how best to ensure that women make decisions about whether or not to undergo testing that are consistent with their beliefs and values This study will explore the extent to which women are ambivalent about prenatal testing and determine how they might benefit from counseling aimed at improving the quality of their decision-making
Women 18 years of age and older who are scheduled for a prenatal genetics visit at clinics in Baltimore MD Minneapolis MN Binghamton NY Salt Lake City UT Washington DC and Bellevue WA and are at increased risk for having a baby with trisomy 21 Down syndrome may be eligible for this study
Participants complete two short questionnaires and a telephone interview about their thoughts and feelings regarding prenatal testing The first two surveys examine the womens thoughts and feelings before and after prenatal counseling Both are completed at the prenatal clinic-one before and one after the counseling session The third survey is done by telephone a few weeks after the prenatal visit to find out if the participant did or did not have prenatal testing and learn about her thoughts and feelings regarding her decision
Detailed Description:
The proposed study seeks to estimate the prevalence of ambivalence about undergoing diagnostic testing among women referred for prenatal genetic counseling and the predictors and decisional consequences of such ambivalence Women seen at six different US prenatal clinics for genetic counseling at increased risk for carrying a fetus with trisomy 21 N240 will be asked to complete a questionnaire on three occasions prior to counseling immediately after counseling and later by telephone These data will be used to describe the extent to which a sample of US women referred for prenatal counseling based upon maternal age or results of a screening test are ambivalent about prenatal testing and might benefit from interventions aimed at improving the quality of decision-making
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-HG-N067 | None | None | None |