Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations
Primary Purpose
Obstetrical Lacerations, Obstetric; Injury Pelvic Floor
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic floor physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Obstetrical Lacerations
Eligibility Criteria
Inclusion Criteria:
- Vaginal delivery at either BIDMC or Mt. Auburn Hospital complicated by either third or fourth degree perineal laceration
- Age 18 or older
Exclusion Criteria:
- History of previous vaginal delivery after 24 weeks gestation
Sites / Locations
- Beth Israel Deaconess Medical Center
- Mount Auburn Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pelvic floor physical therapy
Observatoin
Arm Description
Outcomes
Primary Outcome Measures
Improvement in pelvic floor function (change in PFDI-20)
The primary outcome will be the change in PFDI-20 from baseline to the final assessment at approximately 12-24 weeks postpartum
Secondary Outcome Measures
Full Information
NCT ID
NCT02304016
First Posted
November 26, 2014
Last Updated
February 21, 2019
Sponsor
Boston Urogynecology Associates
1. Study Identification
Unique Protocol Identification Number
NCT02304016
Brief Title
Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations
Official Title
Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Urogynecology Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if patients with third and fourth degree obstetric lacerations benefit from a short course of pelvic floor physical therapy in the immediate postpartum period.
Detailed Description
The proposed study is a prospective, randomized pilot trial. We aim to answer the question: do patients with third and fourth degree obstetric lacerations benefit from a short course pelvic floor physical therapy in the immediate postpartum period?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetrical Lacerations, Obstetric; Injury Pelvic Floor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pelvic floor physical therapy
Arm Type
Experimental
Arm Title
Observatoin
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor physical therapy
Intervention Description
Patients in this arm will be receiving pelvic floor physical therapy
Primary Outcome Measure Information:
Title
Improvement in pelvic floor function (change in PFDI-20)
Description
The primary outcome will be the change in PFDI-20 from baseline to the final assessment at approximately 12-24 weeks postpartum
Time Frame
12-24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Vaginal delivery at either BIDMC or Mt. Auburn Hospital complicated by either third or fourth degree perineal laceration
Age 18 or older
Exclusion Criteria:
History of previous vaginal delivery after 24 weeks gestation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Elkadry, MD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mount Auburn Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32282525
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations
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