Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
NCT ID: NCT05530681
Last Updated: 2024-07-01
Study Results
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Basic Information
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RECRUITING
NA
320 participants
INTERVENTIONAL
2022-08-17
2025-09-01
Brief Summary
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The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS).
Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis.
Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.
The presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct "personal distress", which has been considered as an additional important aspect contributing to sexual dysfunction of women.
PFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Participants
Questionnaire
The survey consists in standardized and validated questionnaires on urinary function (ICIQ-SF, 4 items), bowel function (SMIS, 7 items and PAC-SYM, 12 items), symptoms of prolapse (POPDI, 6 items) and sexual function (Female Sexual Function Index FSFI, 19 items and Female Sexual Distress Scale - Revised FSDS-R, 13 items). questionnaire will be used at recruitment, at the postpartum visit, at the first annual follow-up visit.
Pelvic floor ultrasound
Pelvic floor ultrasound is the preferred imaging modality for documenting pelvic floor anatomy during pregnancy or after delivery. This examination is routinely performed in the outpatient clinic during patient visits (including the one year check-up after delivery). The technique used to assess the pelvic floor is described in detail in the 2019 practice parameters issued by IUGA.
Interventions
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Questionnaire
The survey consists in standardized and validated questionnaires on urinary function (ICIQ-SF, 4 items), bowel function (SMIS, 7 items and PAC-SYM, 12 items), symptoms of prolapse (POPDI, 6 items) and sexual function (Female Sexual Function Index FSFI, 19 items and Female Sexual Distress Scale - Revised FSDS-R, 13 items). questionnaire will be used at recruitment, at the postpartum visit, at the first annual follow-up visit.
Pelvic floor ultrasound
Pelvic floor ultrasound is the preferred imaging modality for documenting pelvic floor anatomy during pregnancy or after delivery. This examination is routinely performed in the outpatient clinic during patient visits (including the one year check-up after delivery). The technique used to assess the pelvic floor is described in detail in the 2019 practice parameters issued by IUGA.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dutch/English-speaking
* \> 33 weeks gestation
* delivering in UZ Leuven
* vaginal delivery
Exclusion Criteria
* not Dutch/English-speaking
* \< 33 weeks gestation
* not delivering in UZ Leuven
* non-vaginal delivery
* Any disorder, that independently from delivery, affects pelvic floor function or structure, such as, but not limited to musculoskeletal or neurologic diseases.
* any women with drug addiction, cognitive deficit, language-barrier and illiteracy
* any disorder or timing or circumstances, which in the Investigator's opinion represents an obstacle to proper informed consent, or safe and/or compliant participation.
* any prior or simultaneous treatment(s) potentially jeopardising safety or compromising trial integrity.
18 Years
45 Years
FEMALE
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Jan Deprest, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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UZLeuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Jan Deprest, Prof. Dr.
Role: primary
References
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Other Identifiers
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s66245
Identifier Type: -
Identifier Source: org_study_id
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