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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04660708
• Other study ID #: 20.102
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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