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Promoting Effective Recovery From Labor Urinary Incontinence (PERL)

University of Michigan logo

University of Michigan

Status and phase

Completed
Phase 3

Conditions

Perinatal Laceration
Pelvic Organ Prolapse
Second Stage Labor
Urinary Incontinence

Treatments

Behavioral: PME practice and record keeping (in diaries)
Procedure: Data collection
Behavioral: Videotape, routine care, PME instruction
Behavioral: Non-directed or directed,spontaneous or sustained pushing

Study type

Interventional

Funder types

Other

Identifiers

NCT00506116
R01NR4007-9

Details and patient eligibility

About

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).

Full 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.

Enrollment

140 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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