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

NCT ID: NCT04660708

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-15
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

manual physical therapy

Intervention Type: BEHAVIORAL

Previously described in the arm description

Interventions

manual physical therapy

Previously described in the arm description

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Revitalize Physical Therapy

UNKNOWN

Sponsor Role: collaborator

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: lead

Responsible Party

Wendy Huddleston

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brenda Heinecke, DPT

Role: PRINCIPAL_INVESTIGATOR

Revitalize Physical Therapy

Locations

Revitalize Physical Therapy

Hales Corners, Wisconsin, United States

Countries

United States

Other Identifiers

20.102

Identifier Type: -

Identifier Source: org_study_id