Clinical trial NCT00506116: Promoting Effective Recovery From Labor Urinary Incontinence (PERL)
Official title: Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence
Pelvic Organ Prolapse
Perinatal Laceration
Second Stage Labor
Keywords: Pelvic floor muscle training
Self-directed pushing
Antenatal perineal massage
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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).

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 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.

Primary outcomes:
measure: Leakage Index (
timeFrame: 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum
Secondary outcomes:
measure: Perineal status (Digital, speculum, chart review, ultrasound)
timeFrame: 35 week gestation and 6 weeks, 6 months, and 12 months postpartum
measure: Pelvic Organ Prolapse Quantification System (POPQ)
timeFrame: 35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michgan School of Nursing
name: Carolyn M Sampselle, PhD,RNC,FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.