Pregnancy RelatedNCT04660708
Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and Pain
A study testing manual physical therapy in people with Pregnancy Related and Delivery; Injury, Maternal, run by University of Wisconsin, Milwaukee at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Delivery; Injury, Maternal, Pelvic Floor Disorders
- What is being tested?
- manual physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women (any pregnancy, first or subsequent) planning for a vaginal delivery
- 28-34 weeks gestation at the start of treatment
Who cannot join
- Planned c-section
- < 18 years old
- >34 weeks gestation
- Women on pelvic rest
Trial locations and contacts
1 site in 1 country.
United States1 site
Revitalize Physical Therapy
Hales Corners, Wisconsin, 53130
About this study
Official title: Effect of Manual Pelvic Floor Physical Therapy During Pregnancy on Perineal Trauma and Pain in the Post Partum Period
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:
- Does pelvic floor physical therapy during pregnancy decrease the severity of perineal trauma during delivery?
- Does pelvic floor physical therapy during pregnancy decrease the length of the second stage of labor (pushing)?
- Does pelvic floor physical therapy during pregnancy decrease the occurrence of emergency C-section?
Read the 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:
- Does pelvic floor PT (physical therapy) during pregnancy decrease the severity of perineal trauma during delivery?
- Does pelvic floor PT during pregnancy decrease the length of the second stage of labor (pushing)?
- Does pelvic floor PT during pregnancy decrease the occurrence of emergency C-section?
- 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.
- Being tested
- manual physical therapy
- Keywords
- Manual therapy, physical therapy, post partum
- Medical subject headings
- Wounds and Injuries, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual physical therapyBehavioural
Previously described in the arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: manual physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 weeks
Pregnancy Mobility Index
standardized survey to determine functional mobility post partum (0 - 72 with a higher score indicating greater impairment)
Measured: 7 weeks
Delivery type
natural or cesarean section (categorical data)
Measured: 7 weeks
Length of labor
length of labor measured in hours
Measured: 7 weeks
Amount of perineal tearing
measured in cm
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start15 Feb 2020
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-cohort quasi-experimental longitudinal interventions study
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- Revitalize Physical Therapy
- Responsible party
- Principal investigator, Wendy Huddleston, University of Wisconsin, Milwaukee
- Investigators
- Brenda Heinecke, DPT, Principal investigator, Revitalize Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660708
- Sponsor's protocol ID
- 20.102
- Status last verified
- May 2022
- First submitted
- 4 Nov 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Pelvic Floor Physical Therapy During Pregnancy on Perineal Trauma and Pain in the Post Partum Period
- ClinicalTrials.gov ID
- NCT04660708
- Acronym / sponsor ID
- 20.102
- Keywords
- Manual therapy, physical therapy, post partum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- Revitalize Physical Therapy
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does pelvic floor physical therapy during pregnancy decrease the severity of perineal trauma during delivery?
- Does pelvic floor physical therapy during pregnancy decrease the length of the second stage of labor (pushing)?
- 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:
- Does pelvic floor PT (physical therapy) during pregnancy decrease the severity of perineal trauma during delivery?
- Does pelvic floor PT during pregnancy decrease the length of the second stage of labor (pushing)?
- Does pelvic floor PT during pregnancy decrease the occurrence of emergency C-section?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-cohort quasi-experimental longitudinal interventions study
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Behavioral: manual physical therapyPhysical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women (any pregnancy, first or subsequent) planning for a vaginal delivery
- 28-34 weeks gestation at the start of treatment
Key exclusion criteria (4 listed)
- Planned c-section
- < 18 years old
- >34 weeks gestation
- Women on pelvic rest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual physical therapyPreviously described in the arm description | Behavioural | Pregnant women |
Primary outcome
Quality of Life and Symptoms Distress Inventory
Time frame: 7 weeks
standardized survey to assess level of urinary leakage post partum (0-45 with the higher score indicating greater impairment
Pregnancy Mobility Index
Time frame: 7 weeks
standardized survey to determine functional mobility post partum (0 - 72 with a higher score indicating greater impairment)
Delivery type
Time frame: 7 weeks
natural or cesarean section (categorical data)
Length of labor
Time frame: 7 weeks
length of labor measured in hours
Amount of perineal tearing
Time frame: 7 weeks
measured in cm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Heinecke, DPT principal investigator
Revitalize Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual physical therapy in people with Pregnancy Related and Delivery; Injury, Maternal, run by University of Wisconsin, Milwaukee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life and Symptoms Distress Inventory (time frame: 7 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.