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

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.

Study Overview

• Status: Unknown
• Conditions: Obstetric; Injury Pelvic Floor; Obstetrical Lacerations
• Intervention / Treatment: Behavioral: Pelvic floor physical therapy

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
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Cambridge, Massachusetts, United States, 02138
      • Mount Auburn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12-24 weeks

Collaborators and Investigators

• Sponsor: Boston Urogynecology Associates
• Investigators: Principal Investigator: Eman Elkadry, MD, Harvard Medical School (HMS and HSDM)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: November 26, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: 2014P000141