Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05530681
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2022-07-06
Brief Title:
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DeliverUU
Brief Summary:
This is a single-center prospective cohort study sponsored by the University Hospitals Leuven UZ Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite at the postpartum check-up and 12 months postpartum
The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction PFD binary outcome at one year after delivery with structural changes to the Pelvic Floor Muscles PFM and postpartum evidence of levator avulsion binary indicator as measured by TransPerineal UltraSound TPUS
Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury documented one year after delivery and those who do not to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training PFMT as prescribed in the standard pathway of peripartum care and to use of TPUS images for the development of artificial intelligence tools for automated image analysis
Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records
The presence and severity of PFD will be measured using standardized self-reporting tools Pelvic Organ Prolapse Distress Index POP-DI Patient Assessment Constipation-SYMptoms PAC-SYM International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form ICIQ-SF St Marks Incontinence Score SMIS Female Sexual Function Index FSFI Female Sexual Distress Scale - Revised FSDS-R FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages FSDS-R assesses the construct personal distress which has been considered as an additional important aspect contributing to sexual dysfunction of women
PFD as a clustered outcome being the presence of any kind of pelvic floor dysfunction symptoms will be defined as POP-DI score of 11 OR ICIQ-SF score of 1 OR SMIS score of 1 OR FSFI score 2655 OR FSDS-R score 11
The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction PFD binary outcome at one year after delivery with structural changes to the Pelvic Floor Muscles PFM and postpartum evidence of levator avulsion binary indicator as measured by TransPerineal UltraSound TPUS
Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury documented one year after delivery and those who do not to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training PFMT as prescribed in the standard pathway of peripartum care and to use of TPUS images for the development of artificial intelligence tools for automated image analysis
Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records
The presence and severity of PFD will be measured using standardized self-reporting tools Pelvic Organ Prolapse Distress Index POP-DI Patient Assessment Constipation-SYMptoms PAC-SYM International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form ICIQ-SF St Marks Incontinence Score SMIS Female Sexual Function Index FSFI Female Sexual Distress Scale - Revised FSDS-R FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages FSDS-R assesses the construct personal distress which has been considered as an additional important aspect contributing to sexual dysfunction of women
PFD as a clustered outcome being the presence of any kind of pelvic floor dysfunction symptoms will be defined as POP-DI score of 11 OR ICIQ-SF score of 1 OR SMIS score of 1 OR FSFI score 2655 OR FSDS-R score 11
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None