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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02304016
Other study ID # 2014P000141
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05317364 - Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery Phase 4
Completed NCT06069596 - Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study Phase 4
Completed NCT01045135 - The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound