Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:December 2014
End Date:March 2021

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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.

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.

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
We found this trial at
2
sites
Cambridge, Massachusetts 02144
Phone: 617-667-0824
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-0824
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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