Promoting Effective Recovery From Labor Urinary Incontinence (PERL) (PERL)

July 30, 2007 updated by: University of Michigan

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Perineal status (Digital, speculum, chart review, ultrasound)
Time Frame: 35 week gestation and 6 weeks, 6 months, and 12 months postpartum
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
35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Carolyn M Sampselle, PhD,RNC,FAAN, University of Michgan School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1996

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 23, 2007

First Submitted That Met QC Criteria

July 23, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

July 31, 2007

Last Update Submitted That Met QC Criteria

July 30, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NR4007-9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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