University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT00506116
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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Notify Me18 year and older
Female
Interventional
Phase 3
Ann Arbor, Michigan, 48109, United States
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.
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:
Exclusion criteria
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.
Non-directed, spontaneous pushing (experimental group) with perineal massage vs. directed, sustained pushing during delivery.
Baseline at 20 weeks gestation; longitudinal at 35 weeks gestation, 6 weeks postpartum, 6 months postpartum, and 12 months postpartum
Time frame: 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum
Time frame: 35 week gestation and 6 weeks, 6 months, and 12 months postpartum
Time frame: 35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum
University of Michigan
Other
Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk
Acronym: PERL
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