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Postpartum Pelvic Floor Workshop (PPFW)

Primary Purpose

Pelvic Floor Disorders, Pelvic Floor; Incompetency, Pelvic Floor Muscle Weakness

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pelvic floor workshop
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring postpartum perineal education

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Postpartum (ie no more than 4 weeks postpartum at time of group allocation)
  • Vaginal delivery
  • Sustained one or more of the following insults to perineum/pelvic floor

    • Third or fourth degree laceration
    • Vacuum or forceps assisted vaginal delivery
    • Delivery of macrosomic infant ≥4000g)

Exclusion Criteria:

  • Prior pelvic floor physiotherapy treatment
  • Prior surgical management for pelvic organ prolapse or incontinence
  • Unable to understand English
  • Caesarean delivery
  • Concerns for patient sensitivity - eg if team is aware of neonatal demise, neonate unwell in NICU etc

Sites / Locations

  • Hamilton Health Sciences
  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

One-time in-person workshop with pelvic floor physiotherapist

Standard care

Outcomes

Primary Outcome Measures

Pelvic floor distress inventory
Survey on symptoms of pelvic floor distress
Pelvic floor distress inventory
Survey on symptoms of pelvic floor distress
Pelvic floor distress inventory
Validated survey on symptoms of pelvic floor distress

Secondary Outcome Measures

Adherence to pelvic floor exercises
Investigator generated questions; Difference between groups in proportion who reported adherence to pelvic floor exercises
Seeking medical care for pelvic floor symptoms
Investigator generated questions: Difference between groups in proportion who reported seeking medical care for their symptoms

Full Information

First Posted
February 9, 2021
Last Updated
February 27, 2023
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04754984
Brief Title
Postpartum Pelvic Floor Workshop
Acronym
PPFW
Official Title
A Randomized Trial: Can a Postpartum Pelvic Floor Education Workshop in a High-Risk Population Improve Pelvic Floor Symptoms?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
After having a baby, there are some expected changes in pelvic floor function. However, tearing of the pelvic floor, having a large baby and needing a vacuum or forceps to deliver the baby put women at risk for having pelvic floor disorders. Our study aims to see if, in women who had a high risk for pelvic floor disorders, a pelvic floor education workshop four weeks after delivery can improve pelvic floor disorders compared to those that did not have a workshop.
Detailed Description
There is compelling evidence for the need for perineal education and care, especially in women who have recognized risk factors. For example, 30-50% of women who have a clinically recognized risk factor report anal incontinence, fecal urgency, dyspareunia and perineal pain. Despite this, a study found that less than 50% of women with anal incontinence voice those symptoms unless directly asked about them. Some authors discuss how women may not share these symptoms with their care providers out of the belief that it is a "normal" effect of childbirth. A review of the literature shows that antenatal educational workshops can be an effective means to provide pregnant women with information regarding pelvic floor health, including how modes of delivery impact pelvic floor function. Similarly, antenatal pelvic floor workshops have been found to improve patients' knowledge on pelvic floor health, their practice of pelvic floor muscle exercises and their confidence with these exercises. To our knowledge, there is no literature exploring the role of a postpartum pelvic floor workshop, on managing perineal and pelvic floor symptoms in women who are identified as being at higher risk of developing pelvic floor dysfunction. Our goal is to develop and assess such a workshop.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Pelvic Floor; Incompetency, Pelvic Floor Muscle Weakness, Perineum; Injury
Keywords
postpartum perineal education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to the intervention or control group. The intervention group will receive the perineal education workshop. The control group will receive standard care. Both groups will receive surveys at baseline, 3, 6 and 12 months postpartum to assess pelvic floor distress.
Masking
None (Open Label)
Masking Description
No masking is possible due to the nature of the study.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
One-time in-person workshop with pelvic floor physiotherapist
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor workshop
Intervention Description
Physiotherapist-led workshop on managing pelvic floor symptoms
Primary Outcome Measure Information:
Title
Pelvic floor distress inventory
Description
Survey on symptoms of pelvic floor distress
Time Frame
Differences between groups in the change in score from beginning of study to 3 months post-partum
Title
Pelvic floor distress inventory
Description
Survey on symptoms of pelvic floor distress
Time Frame
Differences between groups in the change in score from beginning of study to 6 months post-partum
Title
Pelvic floor distress inventory
Description
Validated survey on symptoms of pelvic floor distress
Time Frame
Differences between groups in the change in score from beginning of study to 12 months post-partum
Secondary Outcome Measure Information:
Title
Adherence to pelvic floor exercises
Description
Investigator generated questions; Difference between groups in proportion who reported adherence to pelvic floor exercises
Time Frame
From beginning of study to 12 months post-partum
Title
Seeking medical care for pelvic floor symptoms
Description
Investigator generated questions: Difference between groups in proportion who reported seeking medical care for their symptoms
Time Frame
from beginning of study to 12 months post-partum.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postpartum (ie no more than 4 weeks postpartum at time of group allocation) Vaginal delivery Sustained one or more of the following insults to perineum/pelvic floor Third or fourth degree laceration Vacuum or forceps assisted vaginal delivery Delivery of macrosomic infant ≥4000g) Exclusion Criteria: Prior pelvic floor physiotherapy treatment Prior surgical management for pelvic organ prolapse or incontinence Unable to understand English Caesarean delivery Concerns for patient sensitivity - eg if team is aware of neonatal demise, neonate unwell in NICU etc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola Malabarey
Organizational Affiliation
Hamilton Health Sciences, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no place to share IPD with other researchers

Learn more about this trial

Postpartum Pelvic Floor Workshop

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