Condition category
Pregnancy and Childbirth
Date applied
02/02/2005
Date assigned
03/05/2005
Last edited
16/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Halliday

ORCID ID

Contact details

Public Health Genetics Unit
10th floor Murdoch Childrens Research Institute
Flemington Road
Parkville
3052
Australia
+61 (0)3 8341 6260
jane.halliday@mcri.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

237124; ACTRN12606000234516

Study information

Scientific title

A randomised controlled trial of a decision aid for prenatal screening and diagnosis

Acronym

ADEPT

Study hypothesis

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

Ethics Committee of Royal Australian College of General Practitioners gave approval on the 20th December 2004 (ref: NREEC 03-16)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2004

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

500

Participant 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

Recruitment start date

01/08/2004

Recruitment end date

30/04/2006

Locations

Countries of recruitment

Australia

Trial participating centre

Public Health Genetics Unit
Parkville
3052
Australia

Sponsor information

Organisation

Murdoch Childrens Research Institute (MCRI) (Australia)

Sponsor details

Royal Childrens Hospital
Flemington Road
Parkville
3052
Australia
+61 (0)3 8341 6200
jane.halliday@mcri.edu.au

Sponsor type

Research organisation

Website

http://www.mcri.edu.au/

Funders

Funder type

Research council

Funder name

National Health and Medical Research Council (NHMRC) (Australia)

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/16611368
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/18190370

Publication citations

  1. Study protocol

    Nagle C, Lewis S, Meiser B, Metcalfe S, Carlin JB, Bell R, Gunn J, Halliday J, Evaluation of a decision aid for prenatal testing of fetal abnormalities: a cluster randomised trial [ISRCTN22532458]., BMC Public Health, 2006, 6, 96, doi: 10.1186/1471-2458-6-96.

  2. Results

    Nagle C, Gunn J, Bell R, Lewis S, Meiser B, Metcalfe S, Ukoumunne OC, Halliday J, Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458]., BJOG, 2008, 115, 3, 339-347, doi: 10.1111/j.1471-0528.2007.01576.x.

Additional files

Editorial Notes