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Trial registered on ANZCTR


Registration number
ACTRN12613000192785
Ethics application status
Approved
Date submitted
14/02/2013
Date registered
18/02/2013
Date last updated
13/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating web-based pelvic floor muscle education for pregnant women
Scientific title
Randomised Controlled Trial: Evaluating web-based pelvic floor muscle (PFM) education for pregnant women to enhance knowledge and adherence
Secondary ID [1] 281580 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incontinence during pregnancy 287862 0
Knowledge of pelvic floor muscle function and facilitation during pregnancy 287863 0
Condition category
Condition code
Reproductive Health and Childbirth 288223 288223 0 0
Antenatal care
Public Health 288733 288733 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is a web-based PFM education programme designed by a physiotherapist specialised in women's health. The programme information is based on current recommendations from research and designed to raise pregnant women's knowledge and awareness of PFM and encourage participation in PFM exercise programme. There will be 2 Arms. Arm 1 will receive the 5 minute web-based education via a link on the Internet and usual care. Arm 2 will only receive usual care. Usual care is the standard antenatal health care recommended by the Department of Health for pregnant women living in Australia. Usual care does not prohibit women from participating in any education or exercise programmes unless specified by a health care provider as being contra-indicated during an individual's pregnancy.
Arm 1 will receive the intervention at 20 weeks (+/- 1) gestation and be requested to watch the 5 minute web-based education via a link on the Internet, twice. Both Arms will answer a post-intervention questionnaire at 35 weeks (+/- 1) gestation.
Intervention code [1] 286103 0
Behaviour
Intervention code [2] 286275 0
Prevention
Comparator / control treatment
The comparator group of pregnant women will continue to receive usual care only. Usual care does not prohibit women from participating in any education or exercise programmes.
Control group
Active

Outcomes
Primary outcome [1] 288413 0
Level of awareness and knowledge of PFM as measured by pre and post intervention questionnaires
Timepoint [1] 288413 0
21 weeks (+/-1) gestation then 35 weeks (+/-1) gestation
Primary outcome [2] 288414 0
Confidence and motivation of participant as measured by pre and post intervention questionnaires
Timepoint [2] 288414 0
21 weeks (+/-1) gestation then 35 weeks (+/-1) gestation
Primary outcome [3] 288415 0
Level of adherence to PFM exercises as measured by pre and post intervention questionnaires and an exercise diary
Timepoint [3] 288415 0
21 weeks (+/-1) gestation then 35 weeks (+/-1) gestation
Secondary outcome [1] 300096 0
Urinary incontinence as measured by pre and post intervention questionnaires and a bladder diary
Timepoint [1] 300096 0
21 weeks (+/-1) gestation then 35 weeks (+/-1) gestation
Secondary outcome [2] 300097 0
Knowledge of whether treatment for incontinence is available as measured by pre and post intervention questionnaires
Timepoint [2] 300097 0
21 weeks (+/-1) gestation then 35 weeks (+/-1) gestation
Secondary outcome [3] 300098 0
Whether treatment for incontinence was accessed as measured by a post-intervention questionnaire
Timepoint [3] 300098 0
21 weeks (+/-1) gestation then 35 weeks (+/-1) gestation

Eligibility
Key inclusion criteria
21 weeks (+/-1) gestation
Women who have low levels of knowledge of PFM function and facilitation as measured on a Likert Type Scale
Not planning to have a caesarean section
Sufficient levels of English to respond to the pre-intervention survey
Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed with a neurological condition eg Multiple Sclerosis, Cerebrovascular Accident, Acquired Brian Injury
Bed rest prescribed by a doctor

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 participants will answer a pre-intervention questionnaire. Women with low levels of knowledge of PFM function and facilitation and who consent in this questionnaire to being contacted and involved in further research will then sign a consent form. Because the participants are pregnant they will be allocated a number as the consent forms are received. The allocation of participants will be concealed from the researcher and undertaken by a research assistant using sealed opaque numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
On return of the consent form, the participants will be allocated a number from one to 70 using a computerised sequence generation table. The allocation of the participants to either group one or two will be concealed from the researcher and undertaken by a research assistant, who is not involved in the study. The group allocation will be concealed in opaque envelopes labelled outside from one to 70. The researcher will telephone the assistant to ask for the participant’s allocation number in order of recruitment into the trial. Using the envelopes the participants will be allocated to either the intervention (Arm 1) or control (Arm 2) groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a mixed methods study where the quantitative data from the two questionnaires and the diaries will be merged with the qualitative data from the open-ended items in the questionnaires and the semi-structured interviews.
The quantitative data will be analysed using SPSS - General Linear Model, Multivariate Analysis of Variance, t-tests and Chi Square.
The qualitative data will be thematically analysed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/02/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
26/01/2015
Actual
2/02/2014
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 398 0
Rockingham General Hospital - Cooloongup
Recruitment hospital [2] 399 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [3] 400 0
Geraldton Hospital - Geraldton
Recruitment hospital [4] 401 0
Swan Districts Hospital - Middle Swan
Recruitment hospital [5] 427 0
Bentley Health Service - Bentley
Recruitment hospital [6] 428 0
Albany Hospital - Albany
Recruitment hospital [7] 429 0
Bunbury Hospital - Bunbury
Recruitment hospital [8] 430 0
Busselton Hospital - Busselton
Recruitment hospital [9] 431 0
Esperance Hospital - Esperance
Recruitment hospital [10] 432 0
Kalgoorlie Hospital - Kalgoorlie
Recruitment hospital [11] 433 0
Northam Hospital - Northam
Recruitment postcode(s) [1] 6188 0
6168 - Rockingham
Recruitment postcode(s) [2] 6189 0
6112 - Armadale
Recruitment postcode(s) [3] 6190 0
6530 - Geraldton
Recruitment postcode(s) [4] 6191 0
6056 - Midland
Recruitment postcode(s) [5] 6192 0
6102 - Bentley
Recruitment postcode(s) [6] 6193 0
6330 - Albany
Recruitment postcode(s) [7] 6194 0
6230 - Bunbury
Recruitment postcode(s) [8] 6195 0
6280 - Busselton
Recruitment postcode(s) [9] 6196 0
6450 - Esperance
Recruitment postcode(s) [10] 6197 0
6430 - Kalgoorlie
Recruitment postcode(s) [11] 6198 0
6401 - Northam

Funding & Sponsors
Funding source category [1] 286379 0
University
Name [1] 286379 0
The University of Notre Dame Australia (Fremantle Campus)
Country [1] 286379 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia (Fremantle Campus)
Address
School of Physiotherapy
19 Mouat Street, (Box 1225)
FREMANTLE 6959
Western Australia
Country
Australia
Secondary sponsor category [1] 285167 0
None
Name [1] 285167 0
Address [1] 285167 0
Country [1] 285167 0
Other collaborator category [1] 277240 0
Individual
Name [1] 277240 0
Dr Anne-Marie Hill
Address [1] 277240 0
School of Physiotherapy
19 Mouat Street, (Box 1225)
FREMANTLE 6959
Western Australia
Country [1] 277240 0
Australia
Other collaborator category [2] 277241 0
Individual
Name [2] 277241 0
Adjunct Professor Richard Berlach
Address [2] 277241 0
School of Education
19 Mouat Street, (Box 1225)
FREMANTLE 6959
Western Australia
Country [2] 277241 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288450 0
The University of Notre Dame Australia HREC
Ethics committee address [1] 288450 0
Ethics committee country [1] 288450 0
Australia
Date submitted for ethics approval [1] 288450 0
Approval date [1] 288450 0
20/12/2012
Ethics approval number [1] 288450 0
012114F
Ethics committee name [2] 288600 0
Western Australian Country Health Service
Ethics committee address [2] 288600 0
Ethics committee country [2] 288600 0
Australia
Date submitted for ethics approval [2] 288600 0
26/11/2012
Approval date [2] 288600 0
04/02/2013
Ethics approval number [2] 288600 0
2012:44
Ethics committee name [3] 288601 0
South Metropolitan Health Service
Ethics committee address [3] 288601 0
Ethics committee country [3] 288601 0
Australia
Date submitted for ethics approval [3] 288601 0
14/01/2013
Approval date [3] 288601 0
Ethics approval number [3] 288601 0
13/05
Ethics committee name [4] 288602 0
North Metropolitan Health Service
Ethics committee address [4] 288602 0
Ethics committee country [4] 288602 0
Australia
Date submitted for ethics approval [4] 288602 0
18/02/2013
Approval date [4] 288602 0
Ethics approval number [4] 288602 0
2013-043

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

Contacts
Principal investigator
Name 34976 0
Ms Judith Wilson
Address 34976 0
School of Physiotherapy
19 Mouat Street, (Box 1225)
FREMANTLE 6959
Western Australia
Country 34976 0
Australia
Phone 34976 0
+61 8 9443 0229
Fax 34976 0
Email 34976 0
judy.wilson1@my.nd.edu.au
Contact person for public queries
Name 18223 0
Anne-Marie Hill
Address 18223 0
School of Physiotherapy and exercise Science Curtin University GPO Box U1987 Perth Western Australia 6845
Country 18223 0
Australia
Phone 18223 0
+61892664104
Fax 18223 0
Email 18223 0
anne-marie.hill@curtin.edu.au
Contact person for scientific queries
Name 9151 0
Anne-Marie Hill
Address 9151 0
School of Physiotherapy and exercise Science Curtin University GPO Box U1987 Perth Western Australia 6845
Country 9151 0
Australia
Phone 9151 0
+61892664104
Fax 9151 0
Email 9151 0
anne-marie.hill@curtin.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

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