Urinary Incontinence Clinical Trial
— PERLOfficial title:
Promoting Effective Recovery From Labor Urinary Incontinence: Prevention Reducing Birthing Risk
Verified date | May 2007 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 140 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Antonakos CL, Miller JM, Sampselle CM. Indices for studying urinary incontinence and levator ani function in primiparous women. J Clin Nurs. 2003 Jul;12(4):554-61. — View Citation
Armstrong SM, Miller JM, Benson K, Jain S, Panagopoulos K, DeLancey JO, Sampselle CM. Revisiting reliability of quantified perineal ultrasound: Bland and Altman analysis of a new protocol for the rectangular coordinate method. Neurourol Urodyn. 2006;25(7) — View Citation
DeLancey JO, Sampselle CM, Punch MR. Kegel dyspareunia: levator ani myalgia caused by overexertion. Obstet Gynecol. 1993 Oct;82(4 Pt 2 Suppl):658-9. — View Citation
Roberts JM, González CB, Sampselle C. Why do supportive birth attendants become directive of maternal bearing-down efforts in second-stage labor? J Midwifery Womens Health. 2007 Mar-Apr;52(2):134-41. — View Citation
Sampselle CM, Miller JM, Luecha Y, Fischer K, Rosten L. Provider support of spontaneous pushing during the second stage of labor. J Obstet Gynecol Neonatal Nurs. 2005 Nov-Dec;34(6):695-702. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leakage Index ( | 20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum | ||
Secondary | Perineal status (Digital, speculum, chart review, ultrasound) | 35 week gestation and 6 weeks, 6 months, and 12 months postpartum | ||
Secondary | Pelvic Organ Prolapse Quantification System (POPQ) | 35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum |
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