Postpartum Pelvic Floor Workshop

Study Overview
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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.

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

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

Intervention / Treatment
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* Behavioral: Pelvic floor workshop


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>One-time in-person workshop with pelvic floor physiotherapist | Behavioral: Pelvic floor workshop<br>* Physiotherapist-led workshop on managing pelvic floor symptoms<br>|
| No Intervention: Control<br>Standard care | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum perineal education