Actively Recruiting
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
320
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum. 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.
CONDITIONS
Official Title
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to speak Dutch or English
- Pregnant with more than 33 weeks gestation
- Planning to deliver vaginally at University Hospitals Leuven
You will not qualify if you...
- Younger than 18 years
- Not able to speak Dutch or English
- Pregnant with less than 33 weeks gestation
- Not delivering at University Hospitals Leuven
- Having a non-vaginal delivery
- Any disorder affecting pelvic floor function or structure unrelated to delivery, including musculoskeletal or neurologic diseases
- Drug addiction, cognitive deficit, language barrier, or illiteracy
- Any condition or circumstance that prevents giving informed consent or safe participation, as judged by the investigator
- Any prior or simultaneous treatments that could threaten safety or affect the study's integrity
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZLeuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
J
Jan Deprest, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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