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

Not Applicable

Active, not recruiting

• Conditions: Pregnancy Related; Delivery; Injury, Maternal; Pelvic Floor Disorders
• Interventions: Behavioral: manual physical therapy

• Registration Number: NCT04660708
• Lead Sponsor: University of Wisconsin, Milwaukee

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?

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 Timeline

• Study Start: 2020-02-15
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Primary Completion: 2024-10-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 105

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women	manual physical therapy	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Revitalize Physical Therapy; 🇺🇸 Hales Corners, Wisconsin, United States