Postpartum Pelvic Floor Workshop

NCT ID: NCT04754984

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-03-20

Brief Summary

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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

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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.

Conditions

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Pelvic Floor Disorders Pelvic Floor; Incompetency Pelvic Floor Muscle Weakness Perineum; Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking is possible due to the nature of the study.

Study Groups

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Intervention

One-time in-person workshop with pelvic floor physiotherapist

Group Type EXPERIMENTAL

Pelvic floor workshop

Intervention Type BEHAVIORAL

Physiotherapist-led workshop on managing pelvic floor symptoms

Control

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pelvic floor workshop

Physiotherapist-led workshop on managing pelvic floor symptoms

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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Ola Malabarey

Gynecologist, Urogynecology speciality

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ola Malabarey

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences, McMaster University

Locations

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Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2020-10672

Identifier Type: -

Identifier Source: org_study_id

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