Clinical trial NCT04660708: Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain
Official title: Effect of Manual Pelvic Floor Physical Therapy During Pregnancy on Perineal Trauma and Pain in the Post Partum Period
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Delivery; Injury, Maternal
Pelvic Floor Disorders
Keywords: Manual therapy
physical therapy
post partum
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: Revitalize Physical Therapy
First posted: 2020-12-09
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-cohort quasi-experimental longitudinal interventions study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of Life and Symptoms Distress Inventory
timeFrame: 7 weeks
measure: Pregnancy Mobility Index
timeFrame: 7 weeks
measure: Delivery type
timeFrame: 7 weeks
measure: Length of labor
timeFrame: 7 weeks
measure: Amount of perineal tearing
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hales Corners
country: United States
facility: Revitalize Physical Therapy
state: Wisconsin
Study officials:
affiliation: Revitalize Physical Therapy
name: Brenda Heinecke, DPT
role: PRINCIPAL_INVESTIGATOR
References: