Promoting Effective Recovery From Labor Urinary Incontinence (PERL)

NCT00506116 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2007-07-31

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

PME practice and record keeping (in diaries)

BEHAVIORAL

Non-directed or directed,spontaneous or sustained pushing

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

PROCEDURE

Data collection

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

Sponsors & Collaborators

Principal Investigators

  • Carolyn M Sampselle, PhD,RNC,FAAN · University of Michgan School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1996-07-31
Completion
2006-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00506116 on ClinicalTrials.gov