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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2018
Source Universitaire Ziekenhuizen Leuven
Contact Jan Deprest, MD, PhD
Phone +3216344269
Email jan.deprest@uzleuven.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Diagnostic Test:
questionnaire
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.

Locations

Country Name City State
Belgium UZ Leuven Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (10)

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

Outcome

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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