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

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ClinicalTrials.gov Identifier: NCT04660708
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Collaborator:
Revitalize Physical Therapy
Information provided by (Responsible Party):
Wendy Huddleston, University of Wisconsin, Milwaukee

Study Description
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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:

  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?

Condition or disease Intervention/treatment Phase
Pregnancy Related Delivery; Injury, Maternal Pelvic Floor Disorders Behavioral: manual physical therapy Not Applicable

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:

  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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single-cohort quasi-experimental longitudinal interventions study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Manual Pelvic Floor Physical Therapy During Pregnancy on Perineal Trauma and Pain in the Post Partum Period
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pregnant women

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.

 Behavioral: manual physical therapy
Previously described in the arm description


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life and Symptoms Distress Inventory [ Time Frame: 7 weeks ]
    standardized survey to assess level of urinary leakage post partum (0-45 with the higher score indicating greater impairment

  2. Pregnancy Mobility Index [ Time Frame: 7 weeks ]
    standardized survey to determine functional mobility post partum (0 - 72 with a higher score indicating greater impairment)

  3. Delivery type [ Time Frame: 7 weeks ]
    natural or cesarean section (categorical data)

  4. Length of labor [ Time Frame: 7 weeks ]
    length of labor measured in hours

  5. Amount of perineal tearing [ Time Frame: 7 weeks ]
    measured in cm


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660708


Contacts
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Contact: Wendy E Huddleston, PT, PhD 4142293367 huddlest@uwm.edu
Contact: Carlynn Alt, PT, PhD altc@uwm.edu

Locations
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United States, Wisconsin
Revitalize Physical Therapy Recruiting
Hales Corners, Wisconsin, United States, 53130
Contact: Brenda Heinecke, DPT    414-331-2323    brenda@revitalize-pt.com   
Contact: Jen Holt, DPT    4143312323    contact@revitalize-pt.com   
Sponsors and Collaborators
University of Wisconsin, Milwaukee
Revitalize Physical Therapy
Investigators
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Principal Investigator: Brenda Heinecke, DPT Revitalize Physical Therapy
More Information
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Responsible Party: Wendy Huddleston, Associate Professor, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT04660708    
Other Study ID Numbers: 20.102
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wendy Huddleston, University of Wisconsin, Milwaukee:
Manual therapy
physical therapy
post partum
Additional relevant MeSH terms:
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Pelvic Floor Disorders
Pregnancy Complications