ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000234516

Ethics application status

Approved

Date submitted

23/02/2004

Date registered

23/02/2004

Date last updated

23/02/2004

Type of registration

Prospectively registered

Titles & IDs

Public title

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.

Scientific title

Evaluation of a decision aid for prenatal testing of fetal abnormalities compared to a pamphlet on improving women’s informed choice and decreasing decision al conflict: a cluster randomised controlled trial.

Secondary ID [1]

Perinatal Trials Registry: PTR513

Secondary ID [2]

International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN22532458

Universal Trial Number (UTN)

Trial acronym

ADEPT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Women's decision-making regarding prenatal genetic tests.

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention:
A decision aid provided to women for use during the time they are making decisions about prenatal test options.
Both resources are provided to the participating woman by her GP at the time of her first visit in pregnancy (varies from 5 –12 weeks gestation) and are to be used during the time she is making decisions about test options (dependant on test). The duration of use varies from 1 -9 weeks depending on presenting gestation and choice of test.

Intervention code [1]

Other interventions

Comparator / control treatment

Control:
A pamphlet provided to women for use during the time they are making decisions about prenatal test options.

Control group

Active

Outcomes

Primary outcome [1]

Informed choice and decisional conflict

Timepoint [1]

Measured at 14 weeks gestation

Secondary outcome [1]

Acceptability of the decision aid/pamphlet to women and GPs.

Timepoint [1]

Measured at 14 weeks

Secondary outcome [2]

Anxiety, Depression, attitudes to the pregnancy/fetus.

Timepoint [2]

Measured at 14 weeks, 24 weeks and 3 months post partum.

Secondary outcome [3]

Satisfaction with the decision, and decisional regret.

Timepoint [3]

Measured at 24 weeks and 3 months post partum.

Secondary outcome [4]

Changes in informed choice and decisional conflict.

Timepoint [4]

Measured at 24 weeks and 3 months post partum.

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

Not stated

Sex

Females

Can healthy volunteers participate?

Key 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

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

All GPs provided verbal consent to be randomised prior to randomisation and were therefore unaware of the group to which they would be allocated. A statistician independent of the project conducted all randomisation. The allocation schedule was “off site”.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computer generated random list

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

13/08/2004

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

664

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health & Medical Research Council project grant (ID 237124) 2002-2004.

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Jane Halliday, Murdoch Childrens Research Institute

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

the ethics committee of Royal Australian College of General Practices

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/12/2004

Ethics approval number [1]

NREE03-16

Summary

Brief 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 Australia now recommend that:
1. all women pregnant be informed of, and offered screening tests for fetal abnormality and
2. women who are at an increased risk of chromosomal abnormality on the basis of their age or previously affected pregnancy should be informed of, and offerred the choice of screening or diagnostic tests.

This means that an ever-increasing number of women are confronted with information that is complex and women are required to make decisions that are often difficult and confusing.  To date, technological developments have not resulted in commensurate improvements in the resources 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 of fetal abnormalities in the Victorian primary health cre setting using a cluster randomised controlled trial.  Fifty GPs will be randomly allocated to either the intervention or the control arm of the trial.  GPs will recruit 10 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 assessed at 14 weeks gestation

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Cate Nagle

Address

Public Health Genetics
Murdoch Childrens Research Institute
Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 83416370

Fax

+61 3 83416212

cate.nagle@mcri.edu.au

Contact person for scientific queries

Name

Cate Nagle

Address

Public Health Genetics
Murdoch Childrens Research Institute
Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 83416370

Fax

+61 3 83416212

cate.nagle@mcri.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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