Educating Women About Pelvic Floor Disorders During Pregnancy From the 1st to the "4th Trimester": A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
Time Frame: < 5 minutes
Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence. Scored out of 24 with higher scores indicating an increase in knowledge. Minimum value: 0, Maximum value: 24. Higher scores mean better outcome. Lower scores mean worse outcome. This was administrated at time of recruitment and again at 6 weeks postpartum.
Secondary Outcomes
- Pelvic Floor Distress Inventory (PFDI-20)(< 5 minutes)
- Phone Interview(< 10 minutes)