Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001297213
Ethics application status
Approved
Date submitted
30/07/2018
Date registered
1/08/2018
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The incidence of diastasis recti abdominis after cesarean section - cohort study
Scientific title
The incidence of diastasis recti abdominis after cesarean section - cohort study
Secondary ID [1] 295665 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diastasis recti abdominis 309008 0
Condition category
Condition code
Reproductive Health and Childbirth 307904 307904 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
Patients will be given a test of diastasis recti abdominis (DRA) 3rd postpartal day, after 6 weeks, 6 months and 12 months after delivery. The patients will mark the pain place on the body chart.
The patients will be tested in a standardised supine crock-lying position with instruction to perform an abdominal crunch till the shoulderblades were off the bed.The interrectus distance will be palpated using finger widths, just above umbilicus, 4.5 cm above and 4.5 cm below the umbilicus. DRA will be diagnosed as present if the palpated separation at any of the 3 mentioned locations along the linea alba will be <2 finger widths. The test will be performed by physiotherapists and it will take 5 minutes.
Intervention code [1] 301981 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306879 0
Diastasis recti abdominis by diastasis recti abdominis test
Timepoint [1] 306879 0
3 rd postpartal day (primary endpoint), after 6 weeks, 6 months and 12 months after delivery
Secondary outcome [1] 350014 0
Diastasis recti abdominis in primiparas and multiparas by diastasis recti abdominis test
Timepoint [1] 350014 0
3rd postpartal day, after 6 weeks, 6 months and 12 months after delivery
Secondary outcome [2] 350088 0
Pain marked by body chart
Timepoint [2] 350088 0
3 rd postpartal day,6 weeks, 6 months and 12 months after delivery

Eligibility
Key inclusion criteria
Primiparas, multiparas, cesarean section
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
vaginal birth, previous lumbopelvic pain, operation in lumbopelvic or abdominal area

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
For the incidence of diastasis recti abdominis after cesarean section it will be used calculate the frequency. To determine the significance of the conection in frequencies would be used chi aquared test. The corelation between the pain and diastasis recti abdominis will be determinated to Pearson's correlation coefficient. In interpreting the results statistically significant would be the value of P <0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
Date of last participant enrolment
Anticipated
27/09/2020
Actual
Date of last data collection
Anticipated
27/09/2021
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment outside Australia
Country [1] 10687 0
Croatia
State/province [1] 10687 0
Zagreb

Funding & Sponsors
Funding source category [1] 300245 0
Self funded/Unfunded
Name [1] 300245 0
Manuela Filipec
Country [1] 300245 0
Croatia
Primary sponsor type
Individual
Name
Manuela Filipec
Address
Clinical hospital "Sveti Duh"
Department of Physical Medicine and Rehabilitation
Sveti Duh 64
10000 Zagreb
Country
Croatia
Secondary sponsor category [1] 299665 0
None
Name [1] 299665 0
None
Address [1] 299665 0
None
Country [1] 299665 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301068 0
Ethic Committee of Clinical hospital "Sveti Duh"
Ethics committee address [1] 301068 0
Ethics committee country [1] 301068 0
Croatia
Date submitted for ethics approval [1] 301068 0
28/06/2018
Approval date [1] 301068 0
19/07/2018
Ethics approval number [1] 301068 0
011-11147

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

Contacts
Principal investigator
Name 85770 0
Dr Manuela Filipec
Address 85770 0
Clinical hospital "Sveti Duh"
Department of Physical Medicine and Rehabilitation
Sveti Duh 64
10000 Zagreb
Country 85770 0
Croatia
Phone 85770 0
+385913712561
Fax 85770 0
+38513712206
Email 85770 0
[email protected]
Contact person for public queries
Name 85771 0
Manuela Filipec
Address 85771 0
Clinical hospital "Sveti Duh"
Department of Physical Medicine and Rehabilitation
Sveti Duh 64
10000 Zagreb
Country 85771 0
Croatia
Phone 85771 0
+385913712561
Fax 85771 0
+38513712206
Email 85771 0
[email protected]
Contact person for scientific queries
Name 85772 0
Manuela Filipec
Address 85772 0
Clinical hospital "Sveti Duh"
Department of Physical Medicine and Rehabilitation
Sveti Duh 64
10000 Zagreb
Country 85772 0
Croatia
Phone 85772 0
+385913712561
Fax 85772 0
+38513712206
Email 85772 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.