Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID05530681

Correlation of 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

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying women who have given birth vaginally at the University Hospitals Leuven to understand pelvic floor dysfunction (PFD) one year after delivery. The study aims to link self-reported PFD symptoms with changes in pelvic floor muscles and evidence of muscle injury using ultrasound imaging. Investigators also want to compare patient characteristics and examine how women recover and follow pelvic floor muscle training during the postpartum period. They are exploring the use of ultrasound images to develop artificial intelligence tools for automated analysis. Women will undergo pelvic floor ultrasound and complete standardized questionnaires that assess urinary, bowel, prolapse, and sexual function at three key times: upon admission to the labor suite, at the postpartum check-up, and one year after delivery. The ultrasound will document pelvic floor muscle anatomy and potential injuries. The questionnaires used include validated tools like the Pelvic Organ Prolapse Distress Index, International Consultation on Incontinence Questionnaire, and Female Sexual Function Index, among others. Participants will be followed for one year postpartum with assessments including ultrasound measurements and symptom questionnaires. Researchers will gather information from medical records about pregnancy and delivery. The main outcomes measured are urinary and anal incontinence, sexual dysfunction, and constipation at one year. Additional outcomes include detailed pelvic floor muscle injury measures and pelvic organ position. This study does not involve blinding or multiple treatment groups, focusing instead on observation and correlation of clinical and imaging findings over time.

CONDITIONS

Brief 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
  • Dutch or English-speaking
  • Pregnant at or beyond 33 weeks gestation
  • Planning vaginal delivery at University Hospitals Leuven
Not Eligible

You will not qualify if you...

  • Age younger than 18 years
  • Not Dutch or English-speaking
  • Pregnant less than 33 weeks gestation
  • Not delivering at University Hospitals Leuven
  • Delivery by cesarean or other non-vaginal methods
  • Any disorder affecting pelvic floor function or structure unrelated to delivery, such as musculoskeletal or neurological diseases
  • Drug addiction, cognitive deficits, language barriers, or illiteracy
  • Any condition or circumstance that impairs informed consent or safe participation
  • Prior or simultaneous treatments that could affect safety or study integrity

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 year after delivery

Participants complete standardized questionnaires and undergo pelvic floor ultrasound to assess pelvic floor function and anatomy postpartum.

3 visits (in-person) including recruitment, postpartum visit, and 1-year follow-up

Trial Site Locations

Total: 1 location

1

UZLeuven

Leuven, Belgium, 3000

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Research Team

J

Jan Deprest, MD, PhD

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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Published Research Related To This Trial

Constriction of the levator hiatus during instruction of pelvic floor or transversus abdominis contraction: a 4D ultrasound study.

Kari Bø, Ingeborg H Braekken, Memona Majida...

https://pubmed.ncbi.nlm.nih.gov/18806912

Vaginal palpation of pelvic floor muscle strength: inter-test reproducibility and comparison between palpation and vaginal squeeze pressure.

K Bø, H B Finckenhagen

https://pubmed.ncbi.nlm.nih.gov/11580731