Prevalence of Ambivalence Regarding Prenatal Testing
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2004 |
| End Date: | December 2007 |
Facilitating Informed for Prenatal Testing: The Role of Ambivalence
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.
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.
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 U.S. prenatal
clinics for genetic counseling at increased risk for carrying a fetus with trisomy 21
[N=240] 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 U.S. 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.
diagnostic testing among women referred for prenatal genetic counseling, and the predictors
and decisional consequences of such ambivalence. Women seen at six different U.S. prenatal
clinics for genetic counseling at increased risk for carrying a fetus with trisomy 21
[N=240] 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 U.S. 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.
- 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.
We found this trial at
6
sites
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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University of Utah Research is a major component in the life of the U benefiting...
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Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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