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

Effect of Manual Pelvic Floor Physical Therapy During Pregnancy on Perineal Trauma and Pain in the Post Partum Period

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related; Pelvic Floor Disorders; Delivery; Injury, Maternal
• Intervention / Treatment: Behavioral: manual physical therapy

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Hales Corners, Wisconsin, United States, 53130
      • Revitalize Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pregnancy Mobility Index	standardized survey to determine functional mobility post partum (0 - 72 with a higher score indicating greater impairment)	7 weeks
Delivery type	natural or cesarean section (categorical data)	7 weeks
Length of labor	length of labor measured in hours	7 weeks
Amount of perineal tearing	measured in cm	7 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Milwaukee
• Collaborators: Revitalize Physical Therapy
• Investigators: Principal Investigator: Brenda Heinecke, DPT, Revitalize Physical Therapy

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: physical therapy; Manual therapy; post partum
• Additional Relevant MeSH Terms: Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: 20.102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No