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

NCT04660708 | Unknown

• 1 other identifier: 20.102
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Manual therapy; physical therapy; post partum

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Pregnant women

EXPERIMENTAL

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

Interventions

manual physical therapy BEHAVIORAL

Previously described in the arm description

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women (any pregnancy, first or subsequent) planning for a vaginal delivery
• weeks gestation at the start of treatment

You may not qualify if:

• Planned c-section
• \< 18 years old
• \>34 weeks gestation
• Women on pelvic rest

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• Revitalize Physical Therapy: collaborator

Study Sites (1)

Revitalize Physical Therapy

Hales Corners, Wisconsin, 53130, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Brenda Heinecke, DPT

  Revitalize Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: single-cohort quasi-experimental longitudinal interventions study

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: December 9, 2020
• Study Start: February 15, 2020
• Primary Completion: October 1, 2024
• Study Completion: December 31, 2025
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)