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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04660708
Other study ID # 20.102
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 15, 2020
Est. completion date December 31, 2025

Study information

Verified date May 2022
Source University of Wisconsin, Milwaukee
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to explore the impact of pelvic floor physical therapy during pregnancy on delivery and the impact on the woman's body and function. Currently there have not been any studies to our knowledge that have examined this relationship and the outcomes for the pregnant patient. The current research that is available is on pelvic floor training and perineal massage during pregnancy with positive outcomes. The questions we are looking to answer include: 1. Does pelvic floor physical therapy during pregnancy decrease the severity of perineal trauma during delivery? 2. Does pelvic floor physical therapy during pregnancy decrease the length of the second stage of labor (pushing)? 3. Does pelvic floor physical therapy during pregnancy decrease the occurrence of emergency C-section?


Description:

The purpose of this study is to explore the impact of pelvic floor manual physical therapy techniques during pregnancy on delivery and the impact on the woman's body and function. Currently there have not been any studies to our knowledge that have examined this relationship and the outcomes for the pregnant patient. The current research that is available is on pelvic floor training and perineal massage during pregnancy with positive outcomes. Perineal massage is a stretching technique utilized to relax the tissue of the perineum (the area between the vaginal opening and anus), and is considered routine physical therapy standard of care for pregnant women. Myofascial release of the pelvic floor is a specific manual therapy technique to relax the muscles of the pelvic floor which can include the superficial perineal area. Pelvic myofascial release is a technique used for both pregnant women, and women with chronic pelvic pain. In fact, each component of assessment and treatment are routine and standard PT practices (evaluation, manual therapy, exercise, education), however this specific manual therapy treatment protocol has not been studied during pregnancy to assess the benefits on delivery/recovery. The questions we are looking to answer include: 1. Does pelvic floor PT (physical therapy) during pregnancy decrease the severity of perineal trauma during delivery? 2. Does pelvic floor PT during pregnancy decrease the length of the second stage of labor (pushing)? 3. Does pelvic floor PT during pregnancy decrease the occurrence of emergency C-section? 4. Does pelvic floor PT during pregnancy decrease the likelihood and/or severity of postpartum pelvic pain and pelvic dysfunction? By obtaining these findings, it will allow for program design and treatment recommendations within the pregnancy period to minimize delivery trauma and risk for the mother.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 105
Est. completion date December 31, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Pregnant women (any pregnancy, first or subsequent) planning for a vaginal delivery 2. 28-34 weeks gestation at the start of treatment Exclusion Criteria: 1. Planned c-section 2. < 18 years old 3. >34 weeks gestation 4. Women on pelvic rest

Study Design


Intervention

Behavioral:
manual physical therapy
Previously described in the arm description

Locations

Country Name City State
United States Revitalize Physical Therapy Hales Corners Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Milwaukee Revitalize Physical Therapy

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life and Symptoms Distress Inventory standardized survey to assess level of urinary leakage post partum (0-45 with the higher score indicating greater impairment 7 weeks
Primary Pregnancy Mobility Index standardized survey to determine functional mobility post partum (0 - 72 with a higher score indicating greater impairment) 7 weeks
Primary Delivery type natural or cesarean section (categorical data) 7 weeks
Primary Length of labor length of labor measured in hours 7 weeks
Primary Amount of perineal tearing measured in cm 7 weeks
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