Promoting Effective Recovery From Labor Urinary Incontinence (PERL) (PERL)
Primary Purpose
Urinary Incontinence, Pelvic Organ Prolapse, Perinatal Laceration
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Videotape, routine care, PME instruction
PME practice and record keeping (in diaries)
Non-directed or directed,spontaneous or sustained pushing
Data collection
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Incontinence focused on measuring Pelvic floor muscle training, Self-directed pushing, Antenatal perineal massage
Eligibility Criteria
Inclusion Criteria:
Women giving birth for the first time who are:
- Age 18 years or older
- Less than 20 weeks gestation
- Expected vaginal birth without use of epidural analgesia
- Plan to reside in Southeast Michigan for one year following the birth of the infant.
Exclusion Criteria:
- History of genito-urinary or neuro-muscular pathology
- Previous pregnancy carried beyond 20 weeks gestation.
Sites / Locations
- University of Michigan Health System
Outcomes
Primary Outcome Measures
Leakage Index (
Secondary Outcome Measures
Perineal status (Digital, speculum, chart review, ultrasound)
Pelvic Organ Prolapse Quantification System (POPQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00506116
Brief Title
Promoting Effective Recovery From Labor Urinary Incontinence (PERL)
Acronym
PERL
Official Title
Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 woman's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Pelvic Organ Prolapse, Perinatal Laceration, Second Stage Labor
Keywords
Pelvic floor muscle training, Self-directed pushing, Antenatal perineal massage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Videotape, routine care, PME instruction
Intervention Description
A 40 minute videotape about non-directed, spontaneous pushing and/or a videotape of antenatal perineal massage and pelvic muscle exerise (PME) at intake visit. The control women received routine care and PME instruction at intake visit.
Intervention Type
Behavioral
Intervention Name(s)
PME practice and record keeping (in diaries)
Intervention Type
Behavioral
Intervention Name(s)
Non-directed or directed,spontaneous or sustained pushing
Intervention Description
Non-directed, spontaneous pushing (experimental group) with perineal massage vs. directed, sustained pushing during delivery.
Intervention Type
Procedure
Intervention Name(s)
Data collection
Intervention Description
Baseline at 20 weeks gestation; longitudinal at 35 weeks gestation, 6 weeks postpartum, 6 months postpartum, and 12 months postpartum
Primary Outcome Measure Information:
Title
Leakage Index (
Time Frame
20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum
Secondary Outcome Measure Information:
Title
Perineal status (Digital, speculum, chart review, ultrasound)
Time Frame
35 week gestation and 6 weeks, 6 months, and 12 months postpartum
Title
Pelvic Organ Prolapse Quantification System (POPQ)
Time Frame
35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women giving birth for the first time who are:
Age 18 years or older
Less than 20 weeks gestation
Expected vaginal birth without use of epidural analgesia
Plan to reside in Southeast Michigan for one year following the birth of the infant.
Exclusion Criteria:
History of genito-urinary or neuro-muscular pathology
Previous pregnancy carried beyond 20 weeks gestation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn M Sampselle, PhD,RNC,FAAN
Organizational Affiliation
University of Michgan School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8378003
Citation
DeLancey JO, Sampselle CM, Punch MR. Kegel dyspareunia: levator ani myalgia caused by overexertion. Obstet Gynecol. 1993 Oct;82(4 Pt 2 Suppl):658-9.
Results Reference
background
PubMed Identifier
16282227
Citation
Sampselle CM, Miller JM, Luecha Y, Fischer K, Rosten L. Provider support of spontaneous pushing during the second stage of labor. J Obstet Gynecol Neonatal Nurs. 2005 Nov-Dec;34(6):695-702. doi: 10.1177/0884217505281904.
Results Reference
result
PubMed Identifier
12790869
Citation
Antonakos CL, Miller JM, Sampselle CM. Indices for studying urinary incontinence and levator ani function in primiparous women. J Clin Nurs. 2003 Jul;12(4):554-61. doi: 10.1046/j.1365-2702.2003.00747.x.
Results Reference
result
PubMed Identifier
16897749
Citation
Armstrong SM, Miller JM, Benson K, Jain S, Panagopoulos K, DeLancey JO, Sampselle CM. Revisiting reliability of quantified perineal ultrasound: Bland and Altman analysis of a new protocol for the rectangular coordinate method. Neurourol Urodyn. 2006;25(7):731-8. doi: 10.1002/nau.20299.
Results Reference
result
PubMed Identifier
17336819
Citation
Roberts JM, Gonzalez CBP, Sampselle C. Why do supportive birth attendants become directive of maternal bearing-down efforts in second-stage labor? J Midwifery Womens Health. 2007 Mar-Apr;52(2):134-141. doi: 10.1016/j.jmwh.2006.11.005.
Results Reference
result
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Promoting Effective Recovery From Labor Urinary Incontinence (PERL)
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