Educating Women About Pelvic Floor Disorders During Pregnancy

Study Overview
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Brief Summary
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The purpose of this study is to assess the increase in knowledge of pregnant patients regarding pelvic floor disorders when comparing two educational interventions: written handouts vs interactive workshops.

Detailed Description
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Pelvic floor disorders (PFDs) are common and significantly affect the quality of life of many women as they age. Pregnancy has been identified as a major risk factor for developing PFDs later in life. Educating women about PFDs is essential to ensuring that they present to care in a timely manner. No study has investigated different education tools during pregnancy. The proposed study is a randomized controlled trial in pregnant patients comparing two educational tools: written materials about PFDs versus an educational workshops led by pelvic floor physical therapists (PFPTs). Pregnant patients will be recruited in the first and second trimester and randomized at that time. Knowledge will be assessed at baseline and again 6 weeks postpartum using the validated Prolapse and Incontinence Knowledge Questionnaire. Secondary outcomes will be evaluating referral patterns to urogynecology and to PFPTs from general OBGYNs and assessing any pelvic floor symptoms with the pelvic floor disability index (PFDI-20) at baseline and at 6 weeks postpartum.

Official Title
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Educating Women About Pelvic Floor Disorders During Pregnancy From the 1st to the 4th Trimester: A Randomized Clinical Trial

Conditions
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Pelvic Floor Disorders, Stress Urinary Incontinence, Pelvic Organ Prolapse

Intervention / Treatment
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* Other: Written Handouts
* Other: Interactive Workshop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant (prior to 27 weeks gestation) English speaking Greater than 18 years old Exclusion Criteria: Non-english speaking unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Written Group<br>Participants received only written handouts with information about pelvic floor disorders, including risk factors, prevention strategies, and information about possible treatments. They receive these handouts at the time of recruitment during pregnancy and again after delivery. | Other: Written Handouts<br>* The written materials were generated using the collaboration of healthcare communication specialists to generate content that is tailored to a younger age demographic of childbearing age regarding their risk of developing a pelvic floor disorder and what can be done to prevent or treat them in the future.<br>|
| Experimental: Workshop Group<br>Participants received written handouts and attend a virtual interactive workshop with information about pelvic floor disorders, including risk factors, prevention strategies, and information about possible treatments. They receive the handouts at the time of recruitment during pregnancy and again after delivery. The workshop is conducted prior to completion of pregnancy. | Other: Written Handouts<br>* The written materials were generated using the collaboration of healthcare communication specialists to generate content that is tailored to a younger age demographic of childbearing age regarding their risk of developing a pelvic floor disorder and what can be done to prevent or treat them in the future.<br>Other: Interactive Workshop<br>* Participants logged onto a virtual meeting platform and listened to a live 20 minute presentation by a pelvic floor physical therapist followed by time for questions, which were answered live. Participants anonymity was maintained by not allowing participants to view each other's name and disabling sharing of video feeds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolapse and Incontinence Knowledge Questionnaire (PIKQ) | Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence | < 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Floor Distress Inventory (PFDI-20) | Validated questionnaire measuring presence and degree of both of pelvic floor disorder symptoms. | < 5 minutes | 
| Phone Interview | One-on-one phone interviews conducted with participants in the workshop education group who experienced both educational tools. A research team member called them after completion of the study and conducted a brief 3 question interview to understand their opinion of the educational tools. | < 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, education, prolapse, incontinence