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

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ClinicalTrials.gov Identifier: NCT02304016
Recruitment Status : Recruiting
First Posted : December 1, 2014
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eman Elkadry, M.D., Boston Urogynecology Associates

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.

Condition or disease Intervention/treatment Phase
Obstetrical Lacerations Obstetric; Injury Pelvic Floor Behavioral: Pelvic floor physical therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Pelvic Floor Physical Therapy on Patients With 3rd and 4th Degree Obstetrical Lacerations
Study Start Date : December 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pelvic floor physical therapy Behavioral: Pelvic floor physical therapy
Patients in this arm will be receiving pelvic floor physical therapy

No Intervention: Observatoin



Primary Outcome Measures :
  1. Improvement in pelvic floor function (change in PFDI-20) [ Time Frame: 12-24 weeks ]
    The primary outcome will be the change in PFDI-20 from baseline to the final assessment at approximately 12-24 weeks postpartum



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304016


Contacts
Contact: Emily C Von Bargen, DO 617-354-5452 evonbarg@mah.harvard.edu
Contact: Mariam Haviland, MSPH 617-667-0824 mhaviland@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Miriam Haviland, MSPH    617-667-0824    Mhavilan@bidmc.harvard.edu   
Mount Auburn Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Miriam Haviland, MSPH    617-667-0824    Mhavilan@bidmc.harvard.edu   
Sponsors and Collaborators
Boston Urogynecology Associates
Investigators
Principal Investigator: Eman Elkadry, MD Harvard Medical School

Responsible Party: Eman Elkadry, M.D., Clinical Instructor, Boston Urogynecology Associates
ClinicalTrials.gov Identifier: NCT02304016     History of Changes
Other Study ID Numbers: 2014P000141
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries