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

Obstetric; Injury Pelvic Floor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02304016
• Other study ID #: 2014P000141
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 2021

Study information

• Verified date: February 2019
• Source: Boston Urogynecology Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lacerations
• Obstetric; Injury Pelvic Floor
• Obstetrical Lacerations

Intervention

Behavioral:
• Pelvic floor physical therapy
Patients in this arm will be receiving pelvic floor physical therapy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Mount Auburn Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Urogynecology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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