A DEcision aid for Prenatal Testing
| ISRCTN | ISRCTN22532458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22532458 |
| Secondary identifying numbers | 237124; ACTRN12606000234516 |
- 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
Scientific
Public Health Genetics Unit
10th floor Murdoch Childrens Research Institute
Flemington Road
Parkville
3052
Australia
| Phone | +61 (0)3 8341 6260 |
|---|---|
| jane.halliday@mcri.edu.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| 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 | 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 |
| Secondary outcome measures | 1. Anxiety 2. Depression 3. Attachment to the pregnancy/foetus 4. Acceptability of the decision aid to both woman and GP |
| Overall study start date | 01/08/2004 |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
3052
Australia
Sponsor information
Murdoch Childrens Research Institute (MCRI) (Australia)
Research organisation
Research organisation
Royal Childrens Hospital
Flemington Road
Parkville
3052
Australia
| Phone | +61 (0)3 8341 6200 |
|---|---|
| jane.halliday@mcri.edu.au | |
| Website | http://www.mcri.edu.au/ |
"ROR" |
https://ror.org/048fyec77 |
Funders
Funder type
Research council
National Health and Medical Research Council (NHMRC) (Australia)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 13/04/2006 | Yes | No | |
| Results article | Results | 01/02/2008 | Yes | No |
Editorial Notes
18/12/2017: internal review.
