Promoting Effective Recovery From Labor Urinary Incontinence (PERL)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk

Conditions
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Urinary Incontinence, Pelvic Organ Prolapse, Perinatal Laceration, Second Stage Labor

Intervention / Treatment
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* Behavioral: Videotape, routine care, PME instruction
* Behavioral: PME practice and record keeping (in diaries)
* Behavioral: Non-directed or directed,spontaneous or sustained pushing
* Procedure: Data collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Videotape, routine care, PME instruction|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.|
|Behavioral: PME practice and record keeping (in diaries)|nan|
|Behavioral: Non-directed or directed,spontaneous or sustained pushing|Non-directed, spontaneous pushing (experimental group) with perineal massage vs. directed, sustained pushing during delivery.|
|Procedure: Data collection|Baseline at 20 weeks gestation; longitudinal at 35 weeks gestation, 6 weeks postpartum, 6 months postpartum, and 12 months postpartum|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage Index ( |  | 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perineal status (Digital, speculum, chart review, ultrasound) |  | 35 week gestation and 6 weeks, 6 months, and 12 months postpartum | 
| Pelvic Organ Prolapse Quantification System (POPQ) |  | 35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic floor muscle training, Self-directed pushing, Antenatal perineal massage