Prevalence of Ambivalence Regarding Prenatal Testing

Completed

Conditions studied: Pregnancy

In brief

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.

Key facts

Study ID

NCT00342069

Run by

National Human Genome Research Institute (NHGRI)

Starts

2004-12-17

Expected to finish

2007-12-10

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Georgetown University — Washington D.C., District of Columbia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Genetic Counsel Program — Binghamton, New York, United States
• University of Utah — Salt Lake City, Utah, United States
• Eastside Maternal Fetal Medicine — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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