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Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain

Primary Purpose

Pregnancy Related, Delivery; Injury, Maternal, Pelvic Floor Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
manual physical therapy
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related focused on measuring Manual therapy, physical therapy, post partum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Revitalize Physical Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregnant women

Arm Description

Physical assessment for women 20-34 weeks gestation including evaluating pain, back and hip range of motion, strength of hip and abdominal muscles, diastasis recti, and strength, amount of scar tissue from previous pregnancies / deliveries, level of muscle overactivity, and the extent of any prolapse of pelvic floor muscles. Treatment: internal and external myofascial release of the pelvic floor muscles, pelvic floor stretching, and instruction diaphragmatic breathing and exercises for postpartum recovery to perform at home. Exercises include: Pelvic floor stretching: happy baby stretch, deep squat, butterfly stretch; Belly breathing; transverse abdominis contraction, transverse abdominis march, bridge, shoulder blade; Instruction and education on perineal massage and posture.

Outcomes

Primary Outcome Measures

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
Pregnancy Mobility Index
standardized survey to determine functional mobility post partum (0 - 72 with a higher score indicating greater impairment)
Delivery type
natural or cesarean section (categorical data)
Length of labor
length of labor measured in hours
Amount of perineal tearing
measured in cm

Secondary Outcome Measures

Full Information

First Posted
November 4, 2020
Last Updated
May 16, 2022
Sponsor
University of Wisconsin, Milwaukee
Collaborators
Revitalize Physical Therapy
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1. Study Identification

Unique Protocol Identification Number
NCT04660708
Brief Title
Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain
Official Title
Effect of Manual Pelvic Floor Physical Therapy During Pregnancy on Perineal Trauma and Pain in the Post Partum Period
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
Collaborators
Revitalize Physical Therapy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: Does pelvic floor physical therapy during pregnancy decrease the severity of perineal trauma during delivery? Does pelvic floor physical therapy during pregnancy decrease the length of the second stage of labor (pushing)? Does pelvic floor physical therapy during pregnancy decrease the occurrence of emergency C-section?
Detailed 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: Does pelvic floor PT (physical therapy) during pregnancy decrease the severity of perineal trauma during delivery? Does pelvic floor PT during pregnancy decrease the length of the second stage of labor (pushing)? Does pelvic floor PT during pregnancy decrease the occurrence of emergency C-section? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Delivery; Injury, Maternal, Pelvic Floor Disorders
Keywords
Manual therapy, physical therapy, post partum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-cohort quasi-experimental longitudinal interventions study
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregnant women
Arm Type
Experimental
Arm Description
Physical assessment for women 20-34 weeks gestation including evaluating pain, back and hip range of motion, strength of hip and abdominal muscles, diastasis recti, and strength, amount of scar tissue from previous pregnancies / deliveries, level of muscle overactivity, and the extent of any prolapse of pelvic floor muscles. Treatment: internal and external myofascial release of the pelvic floor muscles, pelvic floor stretching, and instruction diaphragmatic breathing and exercises for postpartum recovery to perform at home. Exercises include: Pelvic floor stretching: happy baby stretch, deep squat, butterfly stretch; Belly breathing; transverse abdominis contraction, transverse abdominis march, bridge, shoulder blade; Instruction and education on perineal massage and posture.
Intervention Type
Behavioral
Intervention Name(s)
manual physical therapy
Intervention Description
Previously described in the arm description
Primary Outcome Measure Information:
Title
Quality of Life and Symptoms Distress Inventory
Description
standardized survey to assess level of urinary leakage post partum (0-45 with the higher score indicating greater impairment
Time Frame
7 weeks
Title
Pregnancy Mobility Index
Description
standardized survey to determine functional mobility post partum (0 - 72 with a higher score indicating greater impairment)
Time Frame
7 weeks
Title
Delivery type
Description
natural or cesarean section (categorical data)
Time Frame
7 weeks
Title
Length of labor
Description
length of labor measured in hours
Time Frame
7 weeks
Title
Amount of perineal tearing
Description
measured in cm
Time Frame
7 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women (any pregnancy, first or subsequent) planning for a vaginal delivery 28-34 weeks gestation at the start of treatment Exclusion Criteria: Planned c-section < 18 years old >34 weeks gestation Women on pelvic rest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Heinecke, DPT
Organizational Affiliation
Revitalize Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Revitalize Physical Therapy
City
Hales Corners
State/Province
Wisconsin
ZIP/Postal Code
53130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain

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