A DEcision aid for Prenatal Testing

ISRCTN	ISRCTN22532458
DOI	https://doi.org/10.1186/ISRCTN22532458
Protocol serial number	237124; ACTRN12606000234516
Sponsor	Murdoch Childrens Research Institute (MCRI) (Australia)
Funder	National Health and Medical Research Council (NHMRC) (Australia)

Submission date: 02/02/2005
Registration date: 03/05/2005
Last edited: 18/12/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jane Halliday
Scientific

Public Health Genetics Unit
10th floor Murdoch Childrens Research Institute
Flemington Road
Parkville
3052
Australia

Phone	+61 (0)3 8341 6260
Email	jane.halliday@mcri.edu.au

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of a decision aid for prenatal screening and diagnosis
Study acronym	ADEPT
Study objectives	Compared with pregnant women receiving a pamphlet, pregnant women who receive a decision aid on prenatal testing for foetal abnormality will have: 1. A higher rate of informed choice 2. Less decisional conflict
Ethics approval(s)	Ethics Committee of Royal Australian College of General Practitioners gave approval on the 20th December 2004 (ref: NREEC 03-16)
Health condition(s) or problem(s) studied	Prenatal testing of foetal abnormalities
Intervention	Decision aid versus pamphlet: 1. The decision aid for prenatal testing of foetal abnormalities has been developed using the three steps of the Ottawa Decision Support framework: 1.1. Identifying needs 1.2. Providing decision support 1.3. Evaluating decision support 2. The pamphlet has been developed by Genetic Health Services Victoria (GHSV). The pamphlet contains information on maternal age related risk, screening and diagnostic tests, a table summarising the tests available and what conditions they detect. Data will be collected from women using questionnaires at 14 weeks and 24 weeks gestation.
Intervention type	Other
Primary outcome measure(s)	1. Informed choice, measured by the percentage of women in each arm of the trial identified as making an informed choice using the multi-dimensional measure of informed choice (MMIC) scale 2. Decisional conflict, measured by the difference in mean scores of the Decisional Conflict Scale between women in each arm
Key secondary outcome measure(s)	1. Anxiety 2. Depression 3. Attachment to the pregnancy/foetus 4. Acceptability of the decision aid to both woman and GP
Completion date	30/04/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	500
Key inclusion criteria	Pregnant women attending a participating general practice (GP) were eligible to participate provided they were: 1. Aged 18 years or older 2. Equal to or less than 12 weeks gestation
Key exclusion criteria	1. Non-English speaking 2. Were unable to give written informed consent 3. Required genetic counselling due to a family history of an inherited condition or recurrent risk for foetal abnormality 4. Having already undertaken testing for foetal abnormality in this pregnancy 5. Experiencing vaginal bleeding 6. Currently having a known multiple pregnancy
Date of first enrolment	01/08/2004
Date of final enrolment	30/04/2006

Locations

Countries of recruitment

Australia

Study participating centre

Public Health Genetics Unit

Parkville
3052
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/02/2008		Yes	No
Protocol article	Protocol	13/04/2006		Yes	No

Editorial Notes

18/12/2017: internal review.