Pregnancy Clinical Trial
Official title:
Facilitating Informed for Prenatal Testing: The Role of Ambivalence
Verified date | December 10, 2007 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 women's 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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 10, 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: Women must be equal to or greater than or equal to 18 years of age, speak English and be competent to consent to participate in the study. Participants must be pregnant women at increased risk for carrying a fetus with trisomy 21 determined by maternal age or an abnormal screening test, such as ultrasound and/or triple tests. EXCLUSION CRITERIA: Women will be excluded form participation if they have ever previously undergone prenatal (in current pregnancy or in a past pregnancy) or participated in prenatal genetic counseling. Women will also be excluded from the study if they have a family history (at least one first degree relative) of a genetic condition and are seeking prenatal testing for genetic indication including trisomy 21. Women at increased risk for other chromosomal or genetic conditions will be excluded. Children and men are excluded as women are the patients in prenatal genetics clinic and the ultimate decision-makers about prenatal testing. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Eastside Maternal Fetal Medicine | Bellevue | Washington |
United States | Genetic Counsel Program | Binghamton | New York |
United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
United States | University of Utah | Salt Lake City | Utah |
United States | Georgetown University | Washington, D.C. | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Human Genome Research Institute (NHGRI) |
United States,
Conner M, Povey R, Sparks P, James R, Shepherd R. Moderating role of attitudinal ambivalence within the theory of planned behaviour. Br J Soc Psychol. 2003 Mar;42(Pt 1):75-94. — View Citation
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