Promoting Effective Recovery From Labor Urinary Incontinence (PERL) - Full Text View

Sponsored by:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00506116

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 III

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

Drug Information available for: BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk

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:

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.

Non-directed, spontaneous pushing (experimental group) with perineal massage vs. directed, sustained pushing during delivery.

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:

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.

Contacts and Locations

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 of Results:

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.

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.

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.

Roberts JM, Gonzalez CB, 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):134-41.

Other Publications:

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.

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

Keywords provided by University of Michigan:

Pelvic floor muscle training
Self-directed pushing
Antenatal perineal massage

Study placed in the following topic categories:

Lacerations
Pathological Conditions, Anatomical
Urination Disorders
Gastrointestinal Diseases
Wounds and Injuries
Disorders of Environmental Origin
Intestinal Diseases

Prolapse
Rectal Diseases
Signs and Symptoms
Digestive System Diseases
Urologic Diseases
Urinary Incontinence
Rectal Prolapse

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009