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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

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]

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

diastasis recti

postpartum pelvic floor dysfunction

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Musculoskeletal

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]

Diagnosis / Prognosis

Comparator / control treatment

NO CONTROL GROUP

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

5 days postpartum (primary time point), 6, 12, 24 weeks postpartum

Secondary outcome [1]

-rate of diastasis recti assessed by manual palpation

Timepoint [1]

once within 6-24 weeks postpartum

Secondary outcome [2]

-tone of pelvic floor muscles assessed by manual palpation

Timepoint [2]

once within 6-24 weeks postpartum

Secondary outcome [3]

- resting tone of pelvic floor muscles assessed by perineometry

Timepoint [3]

once within 6-24 weeks postpartum

Secondary outcome [4]

- strength and endurance of pelvic floor muscles assessed by PERFECT scheme and perineometry

Timepoint [4]

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?

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]

Poland

State/province [1]

Warszawa

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Malgorzata Starzec

Address [1]

Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw, Poland
ul. Ksiecia Trojdena 2C
02-109 Warszawa

Country [1]

Poland

Funding source category [2]

University

Name [2]

Warszawski Uniwersytet Medyczny

Address [2]

ul. Zwirki i Wigury 61, 02-091 Warszawa

Country [2]

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]

None

Name [1]

not applicable

Address [1]

not applicable

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bioethics Committee of Medical University of Warsaw

Ethics committee address [1]

ul. Zwirki i Wigury 61, 
02-091 Warszawa

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

06/06/2017

Ethics approval number [1]

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

Ms Malgorzata Starzec

Address

Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw,
ul. Ksiecia Trojdena 2c
02-109 Warszawa, Poland

Country

Poland

Phone

+48 503383584

Fax

[email protected]

Contact person for public queries

Name

Malgorzata Starzec

Address

Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw,
ul. Ksiecia Trojdena 2c
02-109 Warszawa, Poland

Country

Poland

Phone

+48503383584

Fax

[email protected]

Contact person for scientific queries

Name

Malgorzata Starzec

Address

Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw,
ul. Ksiecia Trojdena 2c
02-109 Warszawa, Poland

Country

Poland

Phone

+48503383584

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
12489	Ethical approval					373797-(Uploaded-07-07-2021-06-17-13)-Study-related document.pdf
12490	Informed 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.

Trial Review

Documents added manually

Documents added automatically