Pregnancy Related Clinical Trial
— PFD-BIOfficial title:
Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function - A Prospective Study Through Pregnancy and Post-partum
NCT number | NCT03591393 |
Other study ID # | S60939 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | June 30, 2021 |
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.
Status | Recruiting |
Enrollment | 622 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. — View Citation
Clark A, Skouteris H, Wertheim EH, Paxton SJ, Milgrom J. The relationship between depression and body dissatisfaction across pregnancy and the postpartum: a prospective study. J Health Psychol. 2009 Jan;14(1):27-35. doi: 10.1177/1359105308097940. — View Citation
Dietz HP. Pelvic floor ultrasound: a review. Am J Obstet Gynecol. 2010 Apr;202(4):321-34. doi: 10.1016/j.ajog.2009.08.018. Review. — View Citation
Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. — View Citation
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/Internation — View Citation
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. Review. — View Citation
Lagaert L, Weyers S, Van Kerrebroeck H, Elaut E. Postpartum dyspareunia and sexual functioning: a prospective cohort study. Eur J Contracept Reprod Health Care. 2017 Jun;22(3):200-206. doi: 10.1080/13625187.2017.1315938. Epub 2017 Apr 27. — View Citation
Reimers C, Staer-Jensen J, Siafarikas F, Saltyte-Benth J, Bø K, Ellström Engh M. Change in pelvic organ support during pregnancy and the first year postpartum: a longitudinal study. BJOG. 2016 Apr;123(5):821-9. doi: 10.1111/1471-0528.13432. Epub 2015 Jun — View Citation
Skouteris H, Carr R, Wertheim EH, Paxton SJ, Duncombe D. A prospective study of factors that lead to body dissatisfaction during pregnancy. Body Image. 2005 Dec;2(4):347-61. Epub 2005 Nov 21. — View Citation
Utomo E, Blok BF, Steensma AB, Korfage IJ. Validation of the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) in a Dutch population. Int Urogynecol J. 2014 Apr;25(4):531-44. doi: 10.1007/s00192-013-2263-z. Epub 2014 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change Body Image during and after pregnancy | Body Image Disturbance Questionnaire Score | through study completion, an average of 18 months | |
Secondary | Urethra mobility in cm | Transperineal ultrasound | 11-13 weeks gestation | |
Secondary | Urethra mobility in cm | Transperineal ultrasound | 28-33 weeks gestation | |
Secondary | genital hiatus in cm^2 | Transperineal ultrasound | 11-13 weeks gestation | |
Secondary | genital hiatus in cm^2 | Transperineal ultrasound | 28-33 weeks gestation | |
Secondary | levator ani avulsion | TUI sequence | 11-13 weeks gestation | |
Secondary | levator ani avulsion | TUI sequence | 28-33 weeks gestation | |
Secondary | anal sphincter injury | TUI sequence | 11-13 weeks gestation | |
Secondary | anal sphincter injury | TUI sequence | 28-33 weeks gestation | |
Secondary | Urinary Incontinence | International Consultation Incontinence Questionnaire - short form | 11-13 weeks gestation | |
Secondary | Urinary Incontinence | International Consultation Incontinence Questionnaire - short form | 28-33 weeks gestation | |
Secondary | Urinary Incontinence | International Consultation Incontinence Questionnaire - short form | 3 months postpartum | |
Secondary | Urinary Incontinence | International Consultation Incontinence Questionnaire - short form | 12 months postpartum | |
Secondary | Anal Incontinence | wexner score | 11-13 weeks gestation | |
Secondary | Anal Incontinence | wexner score | 28-33 weeks gestation | |
Secondary | Anal Incontinence | wexner score | 3 months postpartum | |
Secondary | Anal Incontinence | wexner score | 12 months postpartum | |
Secondary | Pelvic Organ Prolapse | Pelvic Organ Prolapse Distress Inventory | 11-13 weeks gestation | |
Secondary | Pelvic Organ Prolapse | Pelvic Organ Prolapse Distress Inventory | 28-33 weeks gestation | |
Secondary | Pelvic Organ Prolapse | Pelvic Organ Prolapse Distress Inventory | 3 months postpartum | |
Secondary | Pelvic Organ Prolapse | Pelvic Organ Prolapse Distress Inventory | 12 months postpartum | |
Secondary | Sexual function | POP/UI Sexual Questionnaire - IUGA revised | 11-13 weeks gestation | |
Secondary | Sexual function | POP/UI Sexual Questionnaire - IUGA revised | 28-33 weeks gestation | |
Secondary | Sexual function | POP/UI Sexual Questionnaire - IUGA revised | 3 months postpartum | |
Secondary | Sexual function | POP/UI Sexual Questionnaire - IUGA revised | 12 months postpartum |
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