Prevalence of Ambivalence Regarding Prenatal Testing

NCT00342069 | Completed

• 2 other identifiers: 99990506705-HG-N067
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Pregnancy

Keywords

Decision Making; Genetic Counseling; Pregnancy Options; Attitudes Toward Reproductive Options; Beliefs About Down Syndrome Risk; Down Syndrome Risk; Pregnancy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (6)

Georgetown University

Washington D.C., District of Columbia, 20007-2197, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Genetic Counsel Program

Binghamton, New York, 13905, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Eastside Maternal Fetal Medicine

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

• 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. doi: 10.1348/014466603763276135.

  PMID: 12713757 BACKGROUND

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: December 17, 2004
• Study Completion: December 10, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-12-10

Locations

US (6)