Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000764235
Ethics application status
Approved
Date submitted
10/10/2017
Date registered
7/05/2018
Date last updated
9/07/2021
Date data sharing statement initially provided
16/04/2019
Date results information initially provided
9/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pregnancy-related Pelvic Girdle Pain - postpartum prevalence and association with pelvic floor muscle dysfunction and diastasis recti.
Scientific title
Pregnancy-related Pelvic Girdle Pain - postpartum prevalence and association with pelvic floor muscle dysfunction and diastasis recti.
Secondary ID [1] 293101 0
NONE
Universal Trial Number (UTN)
U1111-1203-5072
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy-related Pelvic Girdle Pain 305042 0
diastasis recti 305043 0
postpartum pelvic floor dysfunction 305044 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304369 304369 0 0
Physiotherapy
Reproductive Health and Childbirth 305659 305659 0 0
Other reproductive health and childbirth disorders
Musculoskeletal 305660 305660 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ARM 1: Assesment of early postpartum prevalence of pregnancy-related pelvic girdle pain (PGP) among obstetrics department patients (12h-5 days postpartum)
ARM 2: Assesment of a long term postpartum prevalence of PGP (24 weeks follow-up)
ARM 3: Assesment of the PGP association with pelvic floor muscle dysfunction and diastasis recti among patiens 6-24 weeks postpartum with diagnosed PGP

Pelvic girdle pain (PGP) is a common condition during or after pregnancy with pain and disability as most important symptoms. If persistent postpartum can have a significant influence for a young mother's life still 2 years after labour. . PGP associations with pelvic floor dysfunction and diastasis recti were suggested. The study will focus on the observation of PGP prevalence till 24 weeks postpartum and its association with the pelvic floor dysfunction and diastasis recti. The subjects will undergo the manual pelvic floor assessment, perineometry and manual assessment of linea alba.
Intervention code [1] 300302 0
Diagnosis / Prognosis
Comparator / control treatment
NO CONTROL GROUP
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303616 0
percentage of patients with persistent postpartum pelvic girdle pain (at least 2 out of 7 provocation tests):
- posterior pelvic pain provocation test
- distraction test
- compression test
- ASLR
- symphysis pubis palpation
- LDL palpation
- FABER test
Timepoint [1] 303616 0
5 days postpartum (primary time point), 6, 12, 24 weeks postpartum
Secondary outcome [1] 339640 0
-rate of diastasis recti assessed by manual palpation
Timepoint [1] 339640 0
once within 6-24 weeks postpartum
Secondary outcome [2] 344785 0
-tone of pelvic floor muscles assessed by manual palpation
Timepoint [2] 344785 0
once within 6-24 weeks postpartum
Secondary outcome [3] 344786 0
- resting tone of pelvic floor muscles assessed by perineometry
Timepoint [3] 344786 0
once within 6-24 weeks postpartum
Secondary outcome [4] 344787 0
- strength and endurance of pelvic floor muscles assessed by PERFECT scheme and perineometry
Timepoint [4] 344787 0
once within 6-24 weeks postpartum

Eligibility
Key inclusion criteria
- minimum 12h postpartum
- agreement for study participation
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- diseases and chronic conditions that could elicit similar to Pelvic Girdle Pain symptoms e.g. Scheuremann disease, ankylosing spondylitis, rheumatoid arthritis, Ehlers-Danlos syndrome, diastasis pubic symphysis
- no agreement to participate in the study
- age less than 18 or more than 40

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Descriptive datas will be presented as frequencies, percentages, means with standard deviations and medians. Study women will be categorised according to clinical variables shortly postpartum and during 6,12,24 weeks follow-up 1) presence of PGP (yes/no) 2) pain locations.
The Mann-Whitney U test will be used for
two-group comparisons and the Kruskal-Wallis test for multigroup comparisons.
For nominal data 2 tests will be performed; Fischer’s exact test as appropriate.

Associations between quality scales will be assesed by Pearson Chi square and between numerical scales by Kendall Tau.

The estimation of sample size for the study will be based on the expected prevalence of postpartum PGP according to previous research.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
1/03/2020
Date of last data collection
Anticipated
30/06/2020
Actual
1/03/2020
Sample size
Target
500
Accrual to date
Final
411
Recruitment outside Australia
Country [1] 9277 0
Poland
State/province [1] 9277 0
Warszawa

Funding & Sponsors
Funding source category [1] 297728 0
Self funded/Unfunded
Name [1] 297728 0
Malgorzata Starzec
Country [1] 297728 0
Poland
Funding source category [2] 302519 0
University
Name [2] 302519 0
Warszawski Uniwersytet Medyczny
Country [2] 302519 0
Poland
Primary sponsor type
Individual
Name
Malgorzata Starzec
Address
Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw, Poland
ul. Ksiecia Trojdena 2C
02-109 Warszawa
Country
Poland
Secondary sponsor category [1] 296756 0
None
Name [1] 296756 0
not applicable
Address [1] 296756 0
not applicable
Country [1] 296756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298795 0
Bioethics Committee of Medical University of Warsaw
Ethics committee address [1] 298795 0
ul. Zwirki i Wigury 61,
02-091 Warszawa
Ethics committee country [1] 298795 0
Poland
Date submitted for ethics approval [1] 298795 0
Approval date [1] 298795 0
06/06/2017
Ethics approval number [1] 298795 0
KB/136/2017

Summary
Brief summary
Persistent postpartum pelvic girdle pain (PGP) can have major influence on young mother's life even years postpartum and a significant socio-economical consequences. The prevalence of persistent postpartum Pelvic Girdle Pain has never been studied in Poland before. There are suggestions that PGP may be related to pelvic floor dysfunction and diastasis recti. The exact association is still not known.
The primary aim of the study will be to assess the prevalence functional disturbances of postpartum pelvic girdle pain among women in early postpartum period and in 24 weeks follow-up. The second aim of the study will be to assess the relationship between postpartum PGP, pelvic floor dysfunction and diastasis recti. For PGP assessment the battery of functional tests and the Pelvic Girdle Questionnaire will be used. To investigate the relationship between PGP, pelvic floor dysfunction and diastasis recti the subjects will additionally undergo manual pelvic floor assesment, perineometry and manual assessment of linea alba.
Trial website
Trial related presentations / publications
Starzec M, Truszczynska-Baszak A, Stuge B, Tarnowski A, Rongies W. Cross-cultural Adaptation of the Pelvic Girdle Questionnaire for the Polish Population. J Manipulative Physiol Ther. 2018;41(8):698-703.
Public notes

Contacts
Principal investigator
Name 78246 0
Ms Malgorzata Starzec
Address 78246 0
Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw,
ul. Ksiecia Trojdena 2c
02-109 Warszawa, Poland
Country 78246 0
Poland
Phone 78246 0
+48 503383584
Fax 78246 0
Email 78246 0
[email protected]
Contact person for public queries
Name 78247 0
Ms Malgorzata Starzec
Address 78247 0
Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw,
ul. Ksiecia Trojdena 2c
02-109 Warszawa, Poland
Country 78247 0
Poland
Phone 78247 0
+48503383584
Fax 78247 0
Email 78247 0
[email protected]
Contact person for scientific queries
Name 78248 0
Ms Malgorzata Starzec
Address 78248 0
Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw,
ul. Ksiecia Trojdena 2c
02-109 Warszawa, Poland
Country 78248 0
Poland
Phone 78248 0
+48503383584
Fax 78248 0
Email 78248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Public sharing of IPD is not included within the consent that is filled by study participants.
Therefore there is a risk that data could be re-used for the purposes that participant do not accept.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12489Ethical approval    373797-(Uploaded-07-07-2021-06-17-13)-Study-related document.pdf
12490Informed consent form    373797-(Uploaded-01-02-2021-05-11-40)-Study-related document.pdf



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.