CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 140 enrolled
Drug / intervention
Videotape, routine care, PME instruction +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00506116
NCT00506116Phase 3Completed
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Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk

University of Michigan·interventional·Posted Jul 25, 2007·Updated Jul 31, 2007

In Brief

A Phase 3 clinical trial evaluating Videotape, routine care, PME instruction, PME practice and record keeping (in diaries), and 2 other interventions for Urinary Incontinence and 3 related conditions. Completed, enrolled 140 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence, Pelvic Organ Prolapse, Perinatal Laceration, Second Stage Labor
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2007
Enrollment StartJul 1, 1996
Study CompletionDec 1, 2006
TodayJul 2, 2026
Posted 18.9 years ago

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.

Data collectionprocedure

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