Promoting Effective Recovery From Labor Urinary Incontinence (PERL)

This study has been completed.
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00506116
First received: July 23, 2007
Last updated: July 30, 2007
Last verified: May 2007
  Purpose

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).


Condition Intervention Phase
Urinary Incontinence
Pelvic Organ Prolapse
Perinatal Laceration
Second Stage Labor
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Leakage Index ( [ Time Frame: 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum ]

Secondary Outcome Measures:
  • Perineal status (Digital, speculum, chart review, ultrasound) [ Time Frame: 35 week gestation and 6 weeks, 6 months, and 12 months postpartum ]
  • Pelvic Organ Prolapse Quantification System (POPQ) [ Time Frame: 35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum ]

Enrollment: 140
Study Start Date: July 1996
Study Completion Date: December 2006
Intervention Details:
    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) 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Women giving birth for the first time who are:

  1. Age 18 years or older
  2. Less than 20 weeks gestation
  3. Expected vaginal birth without use of epidural analgesia
  4. Plan to reside in Southeast Michigan for one year following the birth of the infant.

Exclusion Criteria:

  1. History of genito-urinary or neuro-muscular pathology
  2. Previous pregnancy carried beyond 20 weeks gestation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00506116

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Carolyn M Sampselle, PhD,RNC,FAAN University of Michgan School of Nursing
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00506116     History of Changes
Other Study ID Numbers: R01NR4007-9
Study First Received: July 23, 2007
Last Updated: July 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Pelvic floor muscle training
Self-directed pushing
Antenatal perineal massage

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence
Lacerations
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014