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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 21 July 2021
Main ID:  ACTRN12618000764235
Date of registration: 07/05/2018
Prospective Registration: No
Primary sponsor: Malgorzata Starzec
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.
Date of first enrolment: 01/12/2017
Target sample size: 500
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12618000764235.aspx
Study type:  Observational
Study design:  Purpose: Natural history;Duration: Longitudinal;Selection: Convenience sample;Timing: Prospective;  
Phase:  Not Applicable
Countries of recruitment
Poland
Contacts
Name: Ms Malgorzata Starzec   
Address:  Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw, ul. Ksiecia Trojdena 2c 02-109 Warszawa, Poland Poland
Telephone: +48503383584
Email: m.starzec@outlook.com
Affiliation: 
Name: Ms Malgorzata Starzec   
Address:  Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw, ul. Ksiecia Trojdena 2c 02-109 Warszawa, Poland Poland
Telephone: +48503383584
Email: m.starzec@outlook.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: - minimum 12h postpartum
- agreement for study participation

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


Age minimum: 18 Years
Age maximum: 40 Years
Gender: Females
Health Condition(s) or Problem(s) studied
Physical Medicine / Rehabilitation - Physiotherapy
Musculoskeletal - Other muscular and skeletal disorders
Pregnancy-related Pelvic Girdle Pain;diastasis recti;postpartum pelvic floor dysfunction;
Pregnancy-related Pelvic Girdle Pain
diastasis recti
postpartum pelvic floor dysfunction
Reproductive Health and Childbirth - Other reproductive health and childbirth disorders
Intervention(s)
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.
Primary Outcome(s)
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
[5 days postpartum (primary time point), 6, 12, 24 weeks postpartum]
Secondary Outcome(s)
- resting tone of pelvic floor muscles assessed by perineometry[once within 6-24 weeks postpartum]
-rate of diastasis recti assessed by manual palpation
[once within 6-24 weeks postpartum]
- strength and endurance of pelvic floor muscles assessed by PERFECT scheme and perineometry[once within 6-24 weeks postpartum]
-tone of pelvic floor muscles assessed by manual palpation[once within 6-24 weeks postpartum]
Secondary ID(s)
NONE
Source(s) of Monetary Support
Malgorzata Starzec
Warszawski Uniwersytet Medyczny
Secondary Sponsor(s)
not applicable
Ethics review
Status: Approved
Approval date: 06/06/2017
Contact:
Bioethics Committee of Medical University of Warsaw
Results
Results available: Yes
Date Posted: 09/07/2021
Date Completed: 01/03/2020
URL:
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