Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001182684
Ethics application status
Approved
Date submitted
31/10/2014
Date registered
11/11/2014
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Date results provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a public health intervention to reduce alcohol consumption among pregnant women.
Scientific title
Pregnant women receiving a public health education booklet compared to a control group receiving standard antenatal care to assess improvements in knowledge on the issue of alcohol consumption during pregnancy.
Secondary ID [1] 285571 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption during pregnancy 293403 0
Condition category
Condition code
Public Health 293684 293684 0 0
Health promotion/education
Reproductive Health and Childbirth 293726 293726 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Educational information package providing recipes for non-alcoholic mocktails as well as facts about the harms of alcohol consumption in pregnancy, links to further support, and advice on how to cut back. The information package is in the form of a booklet handed out at antenatal appointments. The booklet will be handed out at baseline only.
Intervention code [1] 290525 0
Other interventions
Comparator / control treatment
Standard antenatal care from midwives, shared care GPs, or obstetricians.
Control group
Active

Outcomes
Primary outcome [1] 293499 0
Knowledge as assessed by percentage of correct answers to 13 true/false statements in "Alcohol use in pregnancy" questionnaire. This questionnaire has been designed specifically for this study, and is based on previous similar questionnaires. It has been tested for validity and reliability.
Timepoint [1] 293499 0
Baseline and at four weeks after birth (approximately 24 weeks after intervention commencement)
Secondary outcome [1] 311177 0
Attitude towards alcohol use in pregnancy as assessed by 8 statements measured on a likert scale ranging from strongly disagree to strongly agree.
Timepoint [1] 311177 0
Baseline and four weeks after birth (approximately 24 weeks after intervention commencement)
Secondary outcome [2] 311178 0
Alcohol consumption rates as measured by questions taken from the National Drug Strategy Household Survey concerning quantity of alcohol consumed in last 12 months, types of alcohol consumed, and regularity of drinking sessions.
Timepoint [2] 311178 0
Baseline and four weeks after birth (approximately 24 weeks after intervention commencement)

Eligibility
Key inclusion criteria
Participants over 18 years of age.
Women receiving antenatal care at the WCH.
Women with a gestational age between 16 and 24 weeks.
Women who have consumed alcohol at some stage in the past.
Participants who agree to be followed up post-delivery to complete a questionnaire.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants unable to comprehend English.
Participants with a current substance abuse problem.
Participants with severe, uncontrolled mental illness.
Participants with cognitive impairment that could interfere with their ability to consent.
Participants who consider themselves non-drinkers.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/11/2014
Actual
17/11/2014
Date of last participant enrolment
Anticipated
Actual
28/08/2015
Date of last data collection
Anticipated
Actual
11/01/2016
Sample size
Target
240
Accrual to date
Final
161
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3110 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 12448 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 8859 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 290175 0
University
Name [1] 290175 0
University of South Australia
Country [1] 290175 0
Australia
Primary sponsor type
Individual
Name
Fiona Crawford-Williams
Address
School of Nursing and Midwifery
Centenary Building
Room C5-48
UniSA City East campus
Frome Road
Adelaide
SA 5001
Country
Australia
Secondary sponsor category [1] 288885 0
Individual
Name [1] 288885 0
Professor Adrian Esterman
Address [1] 288885 0
School of Nursing and Midwifery
Centenary building
Room C4-28
UniSA City East campus
Frome Rd
Adelaide
SA 5001
Country [1] 288885 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291883 0
Women's and Children's Health Network HREC
Ethics committee address [1] 291883 0
Ethics committee country [1] 291883 0
Australia
Date submitted for ethics approval [1] 291883 0
Approval date [1] 291883 0
19/09/2013
Ethics approval number [1] 291883 0
HREC/13/WCHN/121

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52418 0
Dr Fiona Crawford-Williams
Address 52418 0
Institute for Resilient Regions,
University of Southern Queensland
Springfield QLD 4300
Country 52418 0
Australia
Phone 52418 0
+61 7 3470 4255
Fax 52418 0
Email 52418 0
[email protected]
Contact person for public queries
Name 52419 0
Fiona Crawford-Williams
Address 52419 0
School of Nursing and Midwifery
UniSA City East
Frome road
Adelaide
SA 5001
Country 52419 0
Australia
Phone 52419 0
+61 8 83021475
Fax 52419 0
Email 52419 0
[email protected]
Contact person for scientific queries
Name 52420 0
Fiona Crawford-Williams
Address 52420 0
School of Nursing and Midwifery
UniSA City East
Frome road
Adelaide
SA 5001
Country 52420 0
Australia
Phone 52420 0
+61 8 83021475
Fax 52420 0
Email 52420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Individual data may be available upon request to the study investigators.


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.