PPFW: Postpartum Pelvic Floor Workshop

Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Recruiting
CT.gov ID
NCT04754984
Collaborator
(none)
50
2
2
21.9
25
1.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pelvic floor workshop
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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.
Primary Purpose:
Treatment
Official Title:
A Randomized Trial: Can a Postpartum Pelvic Floor Education Workshop in a High-Risk Population Improve Pelvic Floor Symptoms?
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

One-time in-person workshop with pelvic floor physiotherapist

Behavioral: Pelvic floor workshop
Physiotherapist-led workshop on managing pelvic floor symptoms

No Intervention: Control

Standard care

Outcome Measures

Primary Outcome Measures

  1. Pelvic floor distress inventory [Differences between groups in the change in score from beginning of study to 3 months post-partum]

    Survey on symptoms of pelvic floor distress

  2. Pelvic floor distress inventory [Differences between groups in the change in score from beginning of study to 6 months post-partum]

    Survey on symptoms of pelvic floor distress

  3. Pelvic floor distress inventory [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 Outcome Measures

  1. Adherence to pelvic floor exercises [From beginning of study to 12 months post-partum]

    Investigator generated questions; Difference between groups in proportion who reported adherence to pelvic floor exercises

  2. Seeking medical care for pelvic floor symptoms [from beginning of study to 12 months post-partum.]

    Investigator generated questions: Difference between groups in proportion who reported seeking medical care for their symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hamilton Health Sciences Hamilton Ontario Canada L8N 3Z5
2 St. Joseph's Healthcare Hamilton Hamilton Ontario Canada L8N 4A6

Sponsors and Collaborators

  • Hamilton Health Sciences Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ola Malabarey, Gynecologist, Urogynecology speciality, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT04754984
Other Study ID Numbers:
  • 2020-10672
First Posted:
Feb 15, 2021
Last Update Posted:
Oct 25, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ola Malabarey, Gynecologist, Urogynecology speciality, Hamilton Health Sciences Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2021