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Clinical Trials/NCT04754984
NCT04754984
Completed
Not Applicable

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

Hamilton Health Sciences Corporation2 sites in 1 country100 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Floor Disorders
Sponsor
Hamilton Health Sciences Corporation
Enrollment
100
Locations
2
Primary Endpoint
Pelvic floor distress inventory
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
March 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ola Malabarey

Gynecologist, Urogynecology speciality

Hamilton Health Sciences Corporation

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

Outcomes

Primary Outcomes

Pelvic floor distress inventory

Time Frame: Differences between groups in the change in score from beginning of study to 12 months post-partum

Validated survey on symptoms of pelvic floor distress

Secondary Outcomes

  • Adherence to pelvic floor exercises(From beginning of study to 12 months post-partum)
  • Seeking medical care for pelvic floor symptoms(from beginning of study to 12 months post-partum.)

Study Sites (2)

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