NCT02304016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

5.3 years

First QC Date

November 26, 2014

Last Update Submit

February 21, 2019

Conditions

Obstetrical LacerationsObstetric; Injury Pelvic Floor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Pelvic floor physical therapy

EXPERIMENTAL
Behavioral: Pelvic floor physical therapy

Observatoin

NO INTERVENTION

Interventions

Pelvic floor physical therapyBEHAVIORAL

Patients in this arm will be receiving pelvic floor physical therapy

Pelvic floor physical therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vaginal delivery at either BIDMC or Mt. Auburn Hospital complicated by either third or fourth degree perineal laceration
  • Age 18 or older

You may not qualify if:

  • History of previous vaginal delivery after 24 weeks gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mount Auburn Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

  • 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.

    PMID: 32282525DERIVED

Study Officials

  • Eman Elkadry, MD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 1, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2020

Study Completion

March 1, 2021

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

US(2)