ANZCTR - Registration

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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]

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

Urinary Incontinence

Lumbo-pelvic pain

Pelvic floor dysfunction

Body Image

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Reproductive Health and Childbirth

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]

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]

The Roland-Morris Disability Questionnaire

Timepoint [1]

at 6 weeks and 6 months

Secondary outcome [1]

Visual Analogue Scale for pelvic pain

Timepoint [1]

At 6 weeks and 6 months post giving birth

Secondary outcome [2]

ICIQ Incontinence Questionnaire

Timepoint [2]

6 weeks and 6 months

Secondary outcome [3]

Pelvic Floor Distress Inventory- Short Form 20

Timepoint [3]

6 weeks and 6 months

Secondary outcome [4]

Body Image Disturbance Questionairre

Timepoint [4]

6 weeks and 6 months

Secondary outcome [5]

The MBSRQ (Multidimensional Body-Self Relations Questionairre) for Body Image

Timepoint [5]

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]

Hospital

Name [1]

Monash Medical Centre

Address [1]

246 Clayton Rd
Clayton
VIC 3168

Country [1]

Australia

Primary sponsor type

Hospital

Name

Monash Medical Centre

Address

246 Clayton Rd
Clayton
VIC 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Southern Health

Ethics committee address [1]

246 Clayton Rd
Clayton
VIC 3168

Ethics committee country [1]

Date submitted for ethics approval [1]

02/03/2011

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Alesha Southby

Address

Monash Medical Centre
246 Clayton Rd
Clayton
VIC
3168

Country

Australia

Phone

+61 3 95942250

Fax

alesha.southby@southernhealth.org.au

Contact person for scientific queries

Name

Alesha Southby

Address

Monash Medical Centre
246 Clayton Rd
Clayton
VIC
3168

Country

Australia

Phone

+61 3 95942250

Fax

alesha.southby@southernhealth.org.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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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