Main
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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:
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ANZCTR |
Last refreshed on:
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21 July 2021 |
Main ID: |
ACTRN12618000764235 |
Date of registration:
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07/05/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Pregnancy-related Pelvic Girdle Pain - postpartum prevalence and association with pelvic floor muscle dysfunction and diastasis recti.
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Scientific title:
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Pregnancy-related Pelvic Girdle Pain - postpartum prevalence and association with pelvic floor muscle dysfunction and diastasis recti. |
Date of first enrolment:
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01/12/2017 |
Target sample size:
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500 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12618000764235.aspx |
Study type:
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Observational |
Study design:
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Purpose: Natural history;Duration: Longitudinal;Selection: Convenience sample;Timing: Prospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Poland
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Contacts
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Name:
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Ms Malgorzata Starzec
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Address:
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Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw,
ul. Ksiecia Trojdena 2c
02-109 Warszawa, Poland
Poland |
Telephone:
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+48503383584 |
Email:
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m.starzec@outlook.com |
Affiliation:
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Name:
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Ms Malgorzata Starzec
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Address:
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Department of Rehabilitation, Physiotherapy Division. Medical University of Warsaw,
ul. Ksiecia Trojdena 2c
02-109 Warszawa, Poland
Poland |
Telephone:
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+48503383584 |
Email:
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m.starzec@outlook.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Physical Medicine / Rehabilitation - Physiotherapy
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Musculoskeletal - Other muscular and skeletal disorders
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Pregnancy-related Pelvic Girdle Pain;diastasis recti;postpartum pelvic floor dysfunction; Pregnancy-related Pelvic Girdle Pain diastasis recti postpartum pelvic floor dysfunction
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Reproductive Health and Childbirth - Other reproductive health and childbirth disorders
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Intervention(s)
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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.
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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- resting tone of pelvic floor muscles assessed by perineometry[once within 6-24 weeks postpartum]
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-rate of diastasis recti assessed by manual palpation
[once within 6-24 weeks postpartum]
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- strength and endurance of pelvic floor muscles assessed by PERFECT scheme and perineometry[once within 6-24 weeks postpartum]
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-tone of pelvic floor muscles assessed by manual palpation[once within 6-24 weeks postpartum]
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Source(s) of Monetary Support
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Malgorzata Starzec
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Warszawski Uniwersytet Medyczny
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Ethics review
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Status: Approved
Approval date: 06/06/2017
Contact:
Bioethics Committee of Medical University of Warsaw
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Results
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Results available:
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Yes |
Date Posted:
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09/07/2021 |
Date Completed:
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01/03/2020 |
URL:
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