Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations
NCT ID: NCT02304016
Last Updated: 2019-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2014-12-31
2021-03-31
Brief Summary
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Detailed Description
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Forty patients experiencing third or fourth degree obstetric laceration at either BIDMC or Mount Auburn Hospital will be identified and randomized in a 1:1 ratio. Half of the patients will receive a 10-12 week course of pelvic floor physical therapy at Marathon PT to begin one to two weeks postpartum. Those assigned to the control will not receive pelvic floor physical therapy which is the current standard of care. They will also agree not to seek pelvic floor physical therapy during until at least 14 weeks postpartum without discussing with study investigators. At 14 weeks postpartum they will be offered pelvic floor physical therapy. At 1-2 weeks postpartum, 6-8 weeks postpartum, and 12-14 weeks postpartum, all study subjects will complete the Pelvic Floor Impact Questionnaire - 7 (PFIQ-7), the Pelvic Floor Distress Inventory - 20 (PFDI-20), the Female Sexual Function Index (FSFI), the Patient Global Impression of Severity (PGI-S) Scale and the Patient Global Impression of Improvement (PGI-I) Scale all of which are validated surveys. Surveys will be completed online via REDCap using computers at Marathon PT for treatment group subjects and at home or in a location of their choosing for control subjects. Control patients will be given the option of beginning pelvic floor PT after 14 weeks postpartum. Should they decide to pursue pelvic floor PT at that time, they will have the option to continue to fill out periodic surveys via REDCap, but will not be required to do so.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pelvic floor physical therapy
Pelvic floor physical therapy
Patients in this arm will be receiving pelvic floor physical therapy
Observatoin
No interventions assigned to this group
Interventions
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Pelvic floor physical therapy
Patients in this arm will be receiving pelvic floor physical therapy
Eligibility Criteria
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Inclusion Criteria
* Age 18 or older
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Boston Urogynecology Associates
OTHER
Responsible Party
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Eman Elkadry, M.D.
Clinical Instructor
Principal Investigators
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Eman Elkadry, MD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School (HMS and HSDM)
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mount Auburn Hospital
Cambridge, Massachusetts, United States
Countries
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References
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Von Bargen E, Haviland MJ, Chang OH, McKinney J, Hacker MR, Elkadry E. Evaluation of Postpartum Pelvic Floor Physical Therapy on Obstetrical Anal Sphincter Injury: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):315-321. doi: 10.1097/SPV.0000000000000849.
Other Identifiers
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2014P000141
Identifier Type: -
Identifier Source: org_study_id
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