Promoting Effective Recovery From Labor Urinary Incontinence (PERL)

University of Michigan140 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

140

Conditions

Urinary Incontinence Pelvic Organ Prolapse Perinatal Laceration Second Stage Labor

Interventions

Videotape, routine care, PME instructionBEHAVIORAL

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.

PME practice and record keeping (in diaries)BEHAVIORAL

Non-directed or directed,spontaneous or sustained pushingBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan Health System

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Leakage Index (

Time frame: 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum

Secondary Outcomes

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

Data from ClinicalTrials.gov

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