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OpenTrials
Completed

NCT Number: NCT00506116

Promoting Effective Recovery From Labor Urinary Incontinence (PERL)

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Videotape, routine care, PME instruction

Behavioral

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 pushing

Behavioral

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

Data collection

Procedure

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

Primary outcomes

  1. Leakage Index (

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

Secondary outcomes

  1. Perineal status (Digital, speculum, chart review, ultrasound)

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

  2. Pelvic Organ Prolapse Quantification System (POPQ)

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk

Acronym: PERL

Important dates

Study start
1996
Study completion
2006
First posted
Jul 25, 2007
Registry last updated
Jul 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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