Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT05530681

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

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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