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Promoting Effective Recovery From Labor Urinary Incontinence (PERL)

NCT ID: NCT00506116

Last Updated: 2007-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Study Completion Date

2006-12-31

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.

Conditions

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Urinary Incontinence Pelvic Organ Prolapse Perinatal Laceration Second Stage Labor

Keywords

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Pelvic floor muscle training Self-directed pushing Antenatal perineal massage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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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.

Intervention Type BEHAVIORAL

PME practice and record keeping (in diaries)

Intervention Type BEHAVIORAL

Non-directed or directed,spontaneous or sustained pushing

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

Intervention Type BEHAVIORAL

Data collection

Baseline at 20 weeks gestation; longitudinal at 35 weeks gestation, 6 weeks postpartum, 6 months postpartum, and 12 months postpartum

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Principal Investigators

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Carolyn M Sampselle, PhD,RNC,FAAN

Role: PRINCIPAL_INVESTIGATOR

University of Michgan School of Nursing

Locations

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University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8378003 (View on PubMed)

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. doi: 10.1177/0884217505281904.

Reference Type RESULT
PMID: 16282227 (View on PubMed)

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. doi: 10.1046/j.1365-2702.2003.00747.x.

Reference Type RESULT
PMID: 12790869 (View on PubMed)

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. doi: 10.1002/nau.20299.

Reference Type RESULT
PMID: 16897749 (View on PubMed)

Roberts JM, Gonzalez CBP, 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):134-141. doi: 10.1016/j.jmwh.2006.11.005.

Reference Type RESULT
PMID: 17336819 (View on PubMed)

Other Identifiers

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R01NR004007

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01NR4007-9

Identifier Type: -

Identifier Source: org_study_id