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Clinical Trials/NCT00686062
NCT00686062
Completed
Not Applicable

Adaptation and Implementation of a Prenatal Genetic Testing Decision-Assisting Tool for Clinical Use

University of California, San Francisco1 site in 1 country494 target enrollmentApril 2001
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
University of California, San Francisco
Enrollment
494
Locations
1
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

This is a randomized study of an interactive, computerized descision-assisting tool for prenatal testing decision making (PT Tool) versus standard educational booklets distributed to all pregnant women by the State of California (control). We hypothesize that, compared to controls, women randomized to view PT Tool will have greater knowledge about prenatal testing and its potential outcomes and better risk comprehension, and that they will be more satisfied with the intervention and have lower decisional conflict.

Detailed Description

We will evaluate the tool in a randomized controlled trial among 500 patients receiving prenatal care at one of the obstetrics clinics and practices affiliated with the University of California at San Francisco (UCSF), San Francisco General Hospital (SFGH), Kaiser San Francisco, or California Pacific Medical Center (CPMC). After completing a baseline questionnaire, participants will be randomized to view either a control or intervention group. Patients assigned to the control group will view the computerized version of the age-appropriate educational pamphlet concerning prenatal testing developed by the State of California. Patients assigned to the intervention group will use the computerized decision support tool/educational module which provides important background information about chromosomal abnormalities, and patient-tailored information about the advantages and limitations of diagnostic testing.

Registry
clinicaltrials.gov
Start Date
April 2001
End Date
April 2004
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Pregnant at less than 24 gestational weeks

Exclusion Criteria

  • Not able to speak English or Spanish

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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