Anal Incontinence, Anorectal Disorder, Body Image, Constipation, Pelvic Organ Prolapse, Postpartum Disorder, Pregnancy Related, Sexual Dysfunction, Urinary Incontinence
Conditions
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.
Interventions
DIAGNOSTIC_TESTquestionnaire
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.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age \> or = 18 years * dutch-speaking * ongoing pregnancy before 14 weeks GA * intending to deliver in UZ Leuven * ICF
Exclusion criteria
* age \< 18 years * not dutch-speaking * non evolutive pregnancy * pregnancy over 14 weeks GA * intention to deliver elsewhere
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Body Image during and after pregnancy | 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
| Measure | Time frame | Description |
|---|---|---|
| genital hiatus in cm^2 | 11-13 weeks gestation | Transperineal ultrasound |
| levator ani avulsion | 11-13 weeks gestation | TUI sequence |
| anal sphincter injury | 11-13 weeks gestation | TUI sequence |
| Urethra mobility in cm | 11-13 weeks gestation | Transperineal ultrasound |
| Anal Incontinence | 11-13 weeks gestation | wexner score: 5-items questionnaire measuring the frequency of complaints. Each item is scored 0-4 (0=never, 4=always). The final score is the sum of the scores of the 5 items (total score 0-20) |
| Pelvic Organ Prolapse | 11-13 weeks gestation | Pelvic Organ Prolapse Distress Inventory |
| Sexual function | 11-13 weeks gestation | POP/UI Sexual Questionnaire - IUGA revised |
| Urinary Incontinence | 11-13 weeks gestation | International Consultation Incontinence Questionnaire - short form |
Countries
Belgium
Outcome results
None listed