Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001638123
Ethics application status
Approved
Date submitted
10/11/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of bracing on early postnatal women with Rectus Abdominis Diastasis.
Scientific title
The effect on the size of the Rectus Abdominis Diastasis of rigid vs elastic bracing on early postnatal women, measured by ultrasound.
Secondary ID [1] 299771 0
None
Universal Trial Number (UTN)
U1111-1243-1813
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectus Abdominis Diastasis 315134 0
Condition category
Condition code
Musculoskeletal 313456 313456 0 0
Other muscular and skeletal disorders
Reproductive Health and Childbirth 313516 313516 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women up to 3 days postnatally at Auckland City Hospital and Birthcare Auckland will be checked using ultrasound for the presence of a Rectus Abdominis Diastasis. Those with this condition will be randomised into two groups and given one of two types of support garment.
Group 1: will be given a postnatal belly belt - Belly Bandit bamboo, to wear for 8 weeks postnatally.
Group 2: will be given a piece of size L tubigrip to wear around their abdomen for 8 weeks postnatally.
The support garments will be given to subjects by a qualified physiotherapist (with at least 10 years experience in treating postnatal women) and advised to wear the support when awake during the day. Their adherence will be monitored with a paper diary.
Standard advice will be given via an education leaflet including exercises (core bracing with activity, pelvic floor exercises, shoulder raises) and advice on activities of daily living (brace when lifting, avoid excessive abdominal muscle strain eg sit ups, don't lift anything heavier than baby, bowel advice to avoid constipation). This leaflet is routinely given to women with rectus abdominis diastasis by the ADHB physiotherapy department.
The rectus abdominis diastasis will be remeasured in both groups 8 weeks postnatally.
Intervention code [1] 316025 0
Treatment: Other
Comparator / control treatment
Tubigrip (elastic support)
Control group
Active

Outcomes
Primary outcome [1] 321925 0
Size of Rectus Abdominis Diastasis measured using ultrasound
Timepoint [1] 321925 0
8 weeks post delivery
Secondary outcome [1] 376721 0
Nil
Timepoint [1] 376721 0
NA

Eligibility
Key inclusion criteria
Women who have given birth either vaginally or via LSCS in the past 3 days, who have been identified as having a rectus abdominis diastasis of greater than 22mm
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with significant history of back or pelvic joint pain
Women with significant spinal abnormality (e.g., scoliosis), inflammatory, rheumatologic neuromuscular or connective tissue disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed - randomised by computer and treatment provided by a different person to that doing ultrasound measurements to determine eligibility for study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Randomisation stratified for age, BMI and parity.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
66 women will be recruited (33 per group).
The collected data will be analysed using IBM SPSS version 24.0. Data will be checked for normality of the distribution using the Kolmogorov and Smirnov test. If parametric, repeated measures ANOVA with planned contrasts will be used to compare RAD distance (primary dependant variable) across the abdominal support conditions at the two anatomical locations (above and below the umbilicus) pre and post intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/11/2019
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
24/04/2020
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 22039 0
New Zealand
State/province [1] 22039 0

Funding & Sponsors
Funding source category [1] 304221 0
Charities/Societies/Foundations
Name [1] 304221 0
A+ trust - ADHB
Country [1] 304221 0
New Zealand
Primary sponsor type
Individual
Name
Jill Depledge
Address
Allied Health
ADHB
Private Bag 92189
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 304458 0
Individual
Name [1] 304458 0
Peter McNair
Address [1] 304458 0
AUT University,
Private Bag 92006,
Auckland 1142
Country [1] 304458 0
New Zealand
Secondary sponsor category [2] 304476 0
Individual
Name [2] 304476 0
Richard Ellis
Address [2] 304476 0
AUT University,
Private Bag 92006,
Auckland 1142
Country [2] 304476 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304682 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 304682 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304682 0
New Zealand
Date submitted for ethics approval [1] 304682 0
16/05/2018
Approval date [1] 304682 0
31/10/2018
Ethics approval number [1] 304682 0

Summary
Brief summary
Diastasis of the rectus abdominis following pregnancy is a common and potentially disabling condition that may lead to herniation of abdominal contents, increased risk of uterine prolapse and back pain during tasks of daily function that involve lifting type activities. We are investigating whether wearing an elastic support garment or a firmer more rigid support belt from immediately after delivery for an 8 week period is more effective in treating this condition.
Women with a diastasis within 3 days of giving birth will be invited to participate, one group will be provided with an elastic support garment, and another group with a more supportive belt. We will then follow them up after 8 weeks to determine which type of garment is more effective in reducing the size of the diastasis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97846 0
Ms Jill Depledge
Address 97846 0
Allied Health
ADHB
Private Bag 92189
Auckland Mail Centre
Auckland 1142
Country 97846 0
New Zealand
Phone 97846 0
+64 9 367000
Fax 97846 0
Email 97846 0
[email protected]
Contact person for public queries
Name 97847 0
Ms Jill Depledge
Address 97847 0
Allied Health
ADHB
Private Bag 92189
Auckland Mail Centre
Auckland 1142
Country 97847 0
New Zealand
Phone 97847 0
+64 9 367000
Fax 97847 0
Email 97847 0
[email protected]
Contact person for scientific queries
Name 97848 0
Ms Jill Depledge
Address 97848 0
Allied Health
ADHB
Private Bag 92189
Auckland Mail Centre
Auckland 1142
Country 97848 0
New Zealand
Phone 97848 0
+64 9 367000
Fax 97848 0
Email 97848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification, will be available
When will data be available (start and end dates)?
Available from March 2020-March 2022
Available to whom?
Anyone on request
Available for what types of analyses?
To discuss with researchers
How or where can data be obtained?
By contacting principal investigator [email protected]


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.