Informed Choice Regarding Invasive Prenatal Testing
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|ClinicalTrials.gov Identifier: NCT00514553|
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : July 2, 2017
This study will compare the effectiveness of two interventions to help women make informed choices about whether or not to undergo an invasive procedure (amniocentesis or chorionic villus sampling) for prenatal testing. The interventions are: 1) conscious deliberation (getting women to focus on and engage in the decision) and 2) unconscious deliberation (getting women not to focus on the decision). Studies suggest that some women are ambivalent about their decisions regarding invasive prenatal testing and those with the most ambivalence experience greater conflict about the decision. Techniques to reduce ambivalence through conscious or unconscious deliberation might lead to better informed choices. The two methods will also be compared with standard counseling for prenatal testing decisions.
Women 18 years of age or older who are referred for prenatal genetic counseling to consider invasive prenatal testing and who have not previously undergone prenatal testing may be eligible for this study.
Participants complete a questionnaire before and after receiving standard genetic counseling. They are then randomly assigned to one of three study groups:
- Standard genetic counseling (control group): Receives no further intervention beyond standard counseling.
- Conscious deliberation: Participants complete a form that focuses their attention on the pros and cons of invasive prenatal testing. This is followed by a brief questionnaire to evaluate time spent thinking about the session and the ease of completing the session.
- Unconscious deliberation: Participants are provided a distraction task to complete during the session, such as a word or number puzzle and are told they will be asked about their decision regarding invasive prenatal testing at the end of the session. This is followed by a brief questionnaire to evaluate time spent thinking about the session and the ease of completing the session.
Participants are contacted by telephone 1 month after the counseling session to find out what they decided regarding invasive prenatal testing and to assess any conflict they experienced about the decision.
|Condition or disease|
|Pregnancy - Prenatal Testing|
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Deliberation With and Without Attention: Can We Enhance Informed Choices About Invasive Prenatal Testing? A Proof of Principle Study|
|Study Start Date :||August 7, 2007|
|Study Completion Date :||May 31, 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514553
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|