Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506116
Status:
COMPLETED
Last Update Posted:
2007-07-31
First Post:
2007-07-23
Brief Title:
Promoting Effective Recovery From Labor Urinary Incontinence PERL
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Promoting Effective Recovery From Labor Urinary Incontinence Prevention Reducing Birthing Risk
Status:
COMPLETED
Status Verified Date:
2007-05
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:
PERL
Brief Summary:
The purpose of this study is to determine whether pushing during labor that is controlled by the woman results in less birth-related injury and less postpartum urinary incontinence UI
Detailed Description:
Birth related urinary incontinence UI is a predictor of UI in older women Ways to protect the continence mechanism during delivery may diminish a womans risk of UI later in life We propose to study the functional anatomy of the pelvic floor as it relates to UI in women who are having their first baby We hypothesize non-directed spontaneous pushing is a protective strategy in decreasing the risk of immediate and long term UI Longitudinal comparisons of pelvic floor characteristics will be taken at 35 week gestation and 6 weeks 6 months and 12 months postpartum Study participants will be seen first at 20 weeks gestation for documentation of baseline levels of pelvic floor function specifically voluntary and involuntary muscle strength urinary continence status and urethral support They will be randomly assigned into non-directed spontaneous experimental and directed sustained pushing control groups Alterations that may occur in urethral support before and after birth will be described through non-invasive urethral ultrasound
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None