Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000395932
Ethics application status
Not yet submitted
Date submitted
7/04/2011
Date registered
14/04/2011
Date last updated
14/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The incidence of lumbo-pelvic pain, pelvic floor dysfunction and body image effects in post-natal women with a clinically significant diastasis of the rectus abdominus muscles (DRAM).
Scientific title
The incidence of lumbo-pelvic pain, pelvic floor dysfunction and body image effects in post-natal women with a clinically significant diastasis of the rectus abdominus muscles (DRAM).
Secondary ID [1] 259947 0
Nil
Universal Trial Number (UTN)
U1111-1120-5595
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diastasis Recti Abdominus Muscle 265565 0
Urinary Incontinence 265566 0
Lumbo-pelvic pain 265567 0
Pelvic floor dysfunction 265568 0
Body Image 265572 0
Condition category
Condition code
Musculoskeletal 265714 265714 0 0
Other muscular and skeletal disorders
Reproductive Health and Childbirth 265780 265780 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational research. Outcome measures for incontinence, lumbo-pelvic pain, pelvic floor dysfunction, body image and measurement of the abdominal muscle seperation. The aim of this study is to investigate the incidence of lumbo-pelvic pain and incontinence and body image in post-natal women, six weeks post birth , (clinically significant DRAM) and then six months after child birth. The incidence of any dysfunction as mentioned will be compared between women with either a) no DRAM (healthy age-matched nulligravida women); b) a clinically insignificant DRAM and c) a clinically significant DRAM. The study will also aim to determine the factors associated with lumbo-pelvic pain and incontinence and body image in post-natal women. The findings of this study will inform the development of a randomized, controlled trial of physiotherapy intervention in women at risk of morbidity following DRAM.
Will aim to recruit all participants and analyse data over a 6 month period.
Intervention code [1] 264358 0
Not applicable
Comparator / control treatment
Control group will have their diastasis recti measured on one occasion and will complete the objective measures on the same occasion regarding body image, lumbo-pelvic pain, pelvic floor dysfunction and incontinence.
Control group
Active

Outcomes
Primary outcome [1] 266477 0
The Roland-Morris Disability Questionnaire
Timepoint [1] 266477 0
at 6 weeks and 6 months
Secondary outcome [1] 273851 0
Visual Analogue Scale for pelvic pain
Timepoint [1] 273851 0
At 6 weeks and 6 months post giving birth
Secondary outcome [2] 273877 0
ICIQ Incontinence Questionnaire
Timepoint [2] 273877 0
6 weeks and 6 months
Secondary outcome [3] 273878 0
Pelvic Floor Distress Inventory- Short Form 20
Timepoint [3] 273878 0
6 weeks and 6 months
Secondary outcome [4] 273879 0
Body Image Disturbance Questionairre
Timepoint [4] 273879 0
6 weeks and 6 months
Secondary outcome [5] 273880 0
The MBSRQ (Multidimensional Body-Self Relations Questionairre) for Body Image
Timepoint [5] 273880 0
at 6 weeks and 6 months

Eligibility
Key inclusion criteria
Post-natal women- 18-45 yrs, english speaking
Healthy Controls-18-45 yrs, engilsh speaking, nulligravida
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Post-natal women- c-section for current birth, older than 45 yrs or younger than 18yrs, non-english speaking

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264828 0
Hospital
Name [1] 264828 0
Monash Medical Centre
Country [1] 264828 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
246 Clayton Rd
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 263935 0
None
Name [1] 263935 0
Address [1] 263935 0
Country [1] 263935 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266801 0
Southern Health
Ethics committee address [1] 266801 0
246 Clayton Rd
Clayton
VIC 3168
Ethics committee country [1] 266801 0
Date submitted for ethics approval [1] 266801 0
02/03/2011
Approval date [1] 266801 0
Ethics approval number [1] 266801 0
11073B

Summary
Brief summary
Diastasis recti (also known as abdominal separation or DRAM) is a disorder defined as a separation of the rectus abdominis muscle into right and left halves. In pregnant or post-natal women, the defect is caused by the stretching of the rectus abdominis by the growing uterus and the increased hormones associated with pregnancy that cause flexibility in the body’s tissues. A clinically significant (larger) DRAM is defined as being greater than or equal to three fingers wide. Although these larger DRAMs are treated by physiotherapists at Southern Health, there is limited evidence into the physical/psychological problems suffered by women in association with a larger DRAM.
The aim of this study is to investigate the incidence of back and pelvic pain, incontinence and body image in post-natal women, immediately post birth (incontinence only), six weeks (whether there is a clinically significant DRAM or other problems) and then six months after child birth. The incidence of any dysfunction as mentioned will be compared between women with either a) no DRAM (healthy age-matched women who have never been pregnant); b) a clinically insignificant DRAM (less than three fingers width) and c) a clinically significant DRAM (three fingers or greater wide). The study will also aim to determine the factors associated with back or pelvic pain, incontinence and body image in post-natal women. The findings of this study will inform the development of a randomized, controlled trial of physiotherapy intervention in women at risk of morbidity following DRAM.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32450 0
Address 32450 0
Country 32450 0
Phone 32450 0
Fax 32450 0
Email 32450 0
Contact person for public queries
Name 15697 0
Alesha Southby
Address 15697 0
Monash Medical Centre
246 Clayton Rd
Clayton
VIC
3168
Country 15697 0
Australia
Phone 15697 0
+61 3 95942250
Fax 15697 0
Email 15697 0
[email protected]
Contact person for scientific queries
Name 6625 0
Alesha Southby
Address 6625 0
Monash Medical Centre
246 Clayton Rd
Clayton
VIC
3168
Country 6625 0
Australia
Phone 6625 0
+61 3 95942250
Fax 6625 0
Email 6625 0
[email protected]

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.