Examining pelvic floor function and ultrasound results one year after childbirth
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
NA · Universitaire Ziekenhuizen KU Leuven · NCT05530681
This study looks at how women's pelvic floor muscles and symptoms change a year after giving birth to see if there's a connection between them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05530681 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study at University Hospitals Leuven aims to investigate the relationship between self-reported pelvic floor dysfunction symptoms and structural changes in pelvic floor muscles one year after vaginal delivery. Participants will undergo pelvic floor ultrasound and complete questionnaires at various points: during labor admission, postpartum check-up, and 12 months postpartum. The study will also explore demographic and obstetric variables related to pelvic floor injury and assess how women cope with pelvic floor dysfunction and their adherence to pelvic floor muscle training. The findings could provide valuable insights into postpartum pelvic health.
Who should consider this trial
Good fit: Ideal candidates are Dutch or English-speaking women aged 18 or older, who are over 33 weeks pregnant and planning to deliver vaginally at UZ Leuven.
Not a fit: Patients who are under 18, do not speak Dutch or English, are less than 33 weeks pregnant, or are not delivering vaginally at UZ Leuven will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of pelvic floor disorders and improve postpartum care for women.
How similar studies have performed: While similar studies have explored pelvic floor dysfunction, this specific correlation between ultrasound findings and self-reported symptoms postpartum is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leuven
- UZLeuven — Leuven, Belgium (RECRUITING)
Study contacts
- Principal investigator: Jan Deprest, MD, PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Jan Deprest, MD, PhD
- Email: jan.deprest@uzleuven.be
- Phone: +3216344269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pelvic Floor Disorders, Obstetric Trauma, Urinary Incontinence, Anal Incontinence, Pelvic Organ Prolapse, Pelvic Pain, Sexual Dysfunction, Constipation