PERINATAL TRIALS REPORT

PT0513

A Decision Aid for prenatal testing for fetal abnormalities

Plain Language Summary:     In recent years new prenatal tests have been developed and these are available earlier in pregnancy. There has also been a dramatic increase in the uptake of screening tests for women in all age groups. Peak obstetric and genetic bodies in Britain, Canada and Austaralia now recommend that:

- all pregnant women be informed of, and offered screening tests for fetal abnormality and

- women who are at an increased risk of chromosomal abnormality on the basis of their age or previously effected pregnancy should be informed of, and offered the choice of screening or diagnostic tests.

This means an ever-increasing number of women are confronted with information that is complex and are required to make decisions that are often difficult and confusing. To date, technological developments have not resulted in commensurate improvements to the resourses available to support women faced with important decisions regarding prenatal testing.

Studies from a variety of health settings such as cancer treatments and hormone replacement therapy, have demonstrated that decision support strategies such as decision aids have facilitated an increase in the capacity of individuals to make an informed choice and have decreased levels of uncertainty and conflict. However the role of decision aids in prenatal testing is not established.

This trial aims to evaluate a decision aid for prenatal testing in the Victorian primary health care setting using a cluster randomised controlled trial. Fifty GPs will recruit 15 consecutive women using pre-specified selection criteria.

The primary outcomes will be the difference in the rate of informed choice and decisional conflict between the two groups. This will be assessed by three questionnaires in pregnancy, at recruitment, at the time of decision making and at 24 weeks gestation. A final questionnaire will be sent at three months after the due date.

Trial status:  Open to accrual

Date trial opened to accrual: April 2004

Expected accrual period: 18 months

Trial Objective:                   

To evaluate the impact of a decision aid on women's experience of decision-making regarding prenatal tests.

Type of administration:        Single Centre

Principal Investigator/s:       A/Prof Jane Halliday

                                         Ph 61 3 8341 6260

                                         Email jane.halliday@mcri.edu.au

Contact Person/s:               Dr Cate Nagle

                                         Ph 61 3 8341 6370

                                         Email cate.nagle@mcri.edu.au

© IMPACT/PSANZ 2001