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Clinical Trials/NCT03591393
NCT03591393
Completed
Not Applicable

Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function - A Prospective Study Through Pregnancy and Post-partum

Universitaire Ziekenhuizen KU Leuven1 site in 1 country328 target enrollmentJuly 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Body Image
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
328
Locations
1
Primary Endpoint
Change Body Image during and after pregnancy
Status
Completed
Last Updated
last year

Overview

Brief Summary

The first objective to determinate the prevalence of pelvic floor dysfunction in pregnant women and in the first year postpartum. The second objective is to assess the anatomical (both clinical and ultrasound), demographic and obstetric variables in symptomatic women and their association with pelvic floor dysfunction, sexual function and Body Image.

This is a single center prospective cohort study. Women will be asked to fill out a questionnaire at the time of their 1st and 3rd trimester scan, at the postpartum checkup and 12 months postpartum. Furthermore, they will undergo a pelvic floor ultrasound at the time of their first and third trimester scan.

The presence of pelvic floor dysfunctions will be recorded through validated self-administered questionnaires with five domains: Wexner questionnaire for anal incontinence, PAC-SYM for constipation, International Consultation on Incontinence Questionnaire Short Form for urinary incontinence, the Pelvic Organ Prolapse Distress Inventory for pelvic organ prolapse, POP/UI Sexual Questionnaire - IUGA revised for sexual function.

The body image perception will be assessed using the Dutch-validated version of the self-administered Body Image Disturbance Questionnaire.

The anatomy of the pelvic floor will be objectively assessed off line on 3D/4D transperineal ultrasound volumes and POP-Q examination. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.

Registry
clinicaltrials.gov
Start Date
July 19, 2018
End Date
June 4, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age \> or = 18 years
  • dutch-speaking
  • ongoing pregnancy before 14 weeks GA
  • intending to deliver in UZ Leuven

Exclusion Criteria

  • age \< 18 years
  • not dutch-speaking
  • non evolutive pregnancy
  • pregnancy over 14 weeks GA
  • intention to deliver elsewhere

Outcomes

Primary Outcomes

Change Body Image during and after pregnancy

Time Frame: through study completion, an average of 18 months

Body Image Disturbance Questionnaire Score: 7-item questionnaire, each item is scored on a 5-point Likert-scale (1=no disturbance at all; 5=extreme disturbance), the final score is the mean of the 7-item ordinal scores.

Secondary Outcomes

  • anal sphincter injury(28-33 weeks gestation)
  • levator ani avulsion(28-33 weeks gestation)
  • Anal Incontinence(12 months postpartum)
  • Urinary Incontinence(12 months postpartum)
  • Urethra mobility in cm(28-33 weeks gestation)
  • Sexual function(12 months postpartum)
  • genital hiatus in cm^2(28-33 weeks gestation)
  • Pelvic Organ Prolapse(12 months postpartum)

Study Sites (1)

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