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
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
Trial website
Trial related presentations / publications
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.