Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women
NCT ID: NCT05004402
Last Updated: 2023-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
345 participants
OBSERVATIONAL
2021-08-04
2023-12-31
Brief Summary
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Material and Methods: Primiparous women after vaginal delivery will be invited to this study. The study will consist of three stages. First phase (baseline measurements) will take place at the hospital and the following assessments will be performed: pelvic floor muscle palpation examination (PERFECT scheme, OXFORD scale, Reissing scale), palpation and ultrasound examination of diastasis recti abdominis. After 12-16 weeks postpartum participants will complete questionnaires about pelvic floor dysfunctions and diastasis recti and their impact on quality of life. Third part, 12-16 weeks postpartum, the pelvic floor muscle examination, palpation and ultrasound examination of diastasis recti abdominis will be repeated.
Objectives: The aim of this study is to assess the function of the pelvic floor muscles, prevalence of pelvic floor dysfunctions and diastasis recti abdominis in the primiparous women postpartum. Our secondary objective will be investigation if there are any prognostics factors during the early postpartum period, that can indicate higher risk of PFD and/or DRA 3 months postpartum.
Expected results: Results of this study will inform about prevalence of pelvic floor dysfunctions and diastasis recti in primiparous women in Poland. Additionally, we hope to obtain predictors suggesting pelvic floor or abdominal muscles dysfunction 3 months postpartum. Prevention of pelvic floor disorders may contribute to the early identification of problems and reduce cost of treatment of unrecognized dysfunction. To our knowledge this will be the first study in this area conducted in Poland.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primiparous women
Primiparous women after vaginal delivery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* First delivery
* Agreement to participate
* Good command of spoken and written Polish
Exclusion Criteria
* Lack of consent to participate in the study
* Lack of good command of spoken and written Polish
18 Years
45 Years
FEMALE
Yes
Sponsors
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Żelazna Medical Centre, LLC
OTHER
Responsible Party
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Principal Investigators
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Małgorzata Starzec-Proserpio, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Midwifery, Centre of Postgraduate Medical Education, Warsaw, Poland
Locations
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St. Sophia's Specialist Hospital
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PN/56/2021
Identifier Type: -
Identifier Source: org_study_id
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