Postpartum Pelvic Floor Workshop (PPFW)

A Randomized Trial: Can a Postpartum Pelvic Floor Education Workshop in a High-Risk Population Improve Pelvic Floor Symptoms?

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Disorders; Pelvic Floor Muscle Weakness; Pelvic Floor; Incompetency; Perineum; Injury
• Intervention / Treatment: Behavioral: Pelvic floor 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

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
No Intervention: Control; Standard care
Experimental: Intervention; One-time in-person workshop with pelvic floor physiotherapist	Behavioral: Pelvic floor workshop; Physiotherapist-led workshop on managing pelvic floor symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor distress inventory	Survey on symptoms of pelvic floor distress	Differences between groups in the change in score from beginning of study to 3 months post-partum
Pelvic floor distress inventory	Survey on symptoms of pelvic floor distress	Differences between groups in the change in score from beginning of study to 6 months post-partum
Pelvic floor distress inventory	Validated survey on symptoms of pelvic floor distress	Differences between groups in the change in score from beginning of study to 12 months post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to pelvic floor exercises	Investigator generated questions; Difference between groups in proportion who reported adherence to pelvic floor exercises	From beginning of study to 12 months post-partum
Seeking medical care for pelvic floor symptoms	Investigator generated questions: Difference between groups in proportion who reported seeking medical care for their symptoms	from beginning of study to 12 months post-partum.

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Ola Malabarey, Hamilton Health Sciences, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: postpartum perineal education
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Muscle Weakness; Pelvic Floor Disorders
• Other Study ID Numbers: 2020-10672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no place to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No