Promoting Effective Recovery From Labor Urinary Incontinence (PERL)

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT00506116
Collaborator
(none)
140
1
125
1.1

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • 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

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single
Primary Purpose:
Prevention
Official Title:
Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk
Study Start Date :
Jul 1, 1996
Actual Study Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Leakage Index ( [20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum]

Secondary Outcome Measures

  1. Perineal status (Digital, speculum, chart review, ultrasound) [35 week gestation and 6 weeks, 6 months, and 12 months postpartum]

  2. Pelvic Organ Prolapse Quantification System (POPQ) [35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00506116
Other Study ID Numbers:
  • R01NR4007-9
First Posted:
Jul 25, 2007
Last Update Posted:
Jul 31, 2007
Last Verified:
May 1, 2007

Study Results

No Results Posted as of Jul 31, 2007