- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00342069
Prevalence of Ambivalence Regarding Prenatal Testing
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Contacts and Locations
Study Locations
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District of Columbia
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Washington, D.C., District of Columbia, United States, 20007-2197
- Georgetown University
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Abbott Northwestern Hospital
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New York
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Binghamton, New York, United States, 13905
- Genetic Counsel Program
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Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah
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Washington
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Bellevue, Washington, United States, 98004
- Eastside Maternal Fetal Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 999905067
- 05-HG-N067
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.
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