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Search / Trial NCT05530681

Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Sep 1, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Urinary Incontinence Anal Incontinence Pelvic Organ Prolapse Sexual Dysfunction Constipation Postpartum Levator Avulsion Anal Sphincter Injury

ClinConnect Summary

This clinical trial is studying how childbirth affects the pelvic floor, which includes the muscles and tissues that support organs in the lower abdomen. The researchers want to understand if there is a link between reported symptoms of pelvic floor problems, like urinary incontinence or pelvic pain, and changes in the pelvic floor that can be seen using an ultrasound one year after delivery. Women participating in the study will be asked to fill out a questionnaire about their symptoms during their hospital admission for labor, at their postpartum check-up, and again one year later.

To be eligible for the trial, women must be at least 18 years old, speak Dutch or English, and be at least 33 weeks pregnant with plans for a vaginal delivery at UZ Leuven hospital. Exclusions include women under 18, those not speaking the required languages, and those with certain health issues that could affect their pelvic floor. Participants can expect to undergo a pelvic floor ultrasound and complete surveys that help evaluate their recovery and symptoms related to pelvic floor dysfunction. Additionally, the study will explore how well women are following pelvic floor exercises as part of their postpartum care.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • age = or \> 18 years
  • Dutch/English-speaking
  • \> 33 weeks gestation
  • delivering in UZ Leuven
  • vaginal delivery
  • Exclusion Criteria:
  • age \< 18 years
  • 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.

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, , Belgium

Patients applied

0 patients applied

Trial Officials

Jan Deprest, MD, PhD

Principal Investigator

Universitaire Ziekenhuizen KU Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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