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NCT00514553 · ClinicalTrials.gov registry record

Informed Choice Regarding Invasive Prenatal Testing

A clinical trial of Pregnancy - Prenatal Testing, sponsored by National Human Genome Research Institute (NHGRI).

Completed
Registry status
37
Enrollment target
1
Study location

NCT00514553: Completed study of Pregnancy - Prenatal Testing, sponsored by National Human Genome Research Institute (NHGRI).

NCT00514553 is a study of Pregnancy - Prenatal Testing that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 37 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00514553, a study of Pregnancy - Prenatal Testing, has completed, sponsored by National Human Genome Research Institute (NHGRI).

COMPLETED
Registry status
37 participants
Enrollment target
1
Study location

Study Summary

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 se

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2007-08-07
Est. Completion 2011-05-31

What the finished NCT00514553 record still lists

NCT00514553 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 37 participants, a relatively small participant target.

The record links to 1 condition, with Pregnancy - Prenatal Testing appearing as the primary indexed condition, and to 0 interventions.

NCT00514553 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00514553 about?

NCT00514553 is a clinical study titled "Informed Choice Regarding Invasive Prenatal Testing". 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 ...

What is the current status of trial NCT00514553?

This trial is currently completed. The enrollment target is 37 participants. The study started on 2007-08-07. Estimated completion is 2011-05-31.

What conditions does trial NCT00514553 study?

This clinical trial studies the following conditions: Pregnancy - Prenatal Testing.

Who is sponsoring clinical trial NCT00514553?

This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00514553 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00514553, the US trial registry maintained by the National Library of Medicine. NCT00514553 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.