The effect of a decision aid for prenatal testing of fetal abnormalities compared to a pamphlet on improving women’s informed choice and decreasing decisional conflict: a randomised controlled trial.
Active, not recruiting
- Conditions
- Women's decision-making regarding prenatal genetic tests.Reproductive Health and Childbirth - Antenatal care
- Registration Number
- ACTRN12606000234516
- Lead Sponsor
- Jane Halliday, Murdoch Childrens Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 664
Inclusion Criteria
Victorian GPs will be eligible for participation provided they consult with least 30 women meeting the selection criteria in a 12-month period. Pregnant attending a participating GP will be eligible if they are: less than 12 weeks gestation.
Exclusion Criteria
1. are non-english speaking2. are unable to give written informed consent3. require genetic counselling due to a familiy history of an inherited disorder4. have not undertaken any testing to date for fetal abnormality in this pregnancy5. are currently experiencing vaginal bleeding6. have a known multiple pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Informed choice and decisional conflict[Measured at 14 weeks gestation]
- Secondary Outcome Measures
Name Time Method Acceptability of the decision aid/pamphlet to women and GPs.[Measured at 14 weeks];Anxiety, Depression, attitudes to the pregnancy/fetus.[Measured at 14 weeks, 24 weeks and 3 months post partum.];Satisfaction with the decision, and decisional regret.[Measured at 24 weeks and 3 months post partum.];Changes in informed choice and decisional conflict.[Measured at 24 weeks and 3 months post partum.]