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Educating Women About Pelvic Floor Disorders During Pregnancy

Not Applicable
Completed
Conditions
Pelvic Floor Disorders
Pelvic Organ Prolapse
Stress Urinary Incontinence
Interventions
Other: Written Handouts
Other: Interactive Workshop
Registration Number
NCT05440539
Lead Sponsor
The Methodist Hospital Research Institute
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
120
Inclusion Criteria
  • Pregnant (prior to 27 weeks gestation)
  • English speaking
  • Greater than 18 years old
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Exclusion Criteria
  • Non-english speaking
  • unable to provide informed consent
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Written GroupWritten HandoutsParticipants 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.
Workshop GroupWritten HandoutsParticipants 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.
Workshop GroupInteractive WorkshopParticipants 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.
Primary Outcome Measures
NameTimeMethod
Prolapse and Incontinence Knowledge Questionnaire (PIKQ)< 5 minutes

Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence

Secondary Outcome Measures
NameTimeMethod
Pelvic Floor Distress Inventory (PFDI-20)< 5 minutes

Validated questionnaire measuring presence and degree of both of pelvic floor disorder symptoms.

Phone Interview< 10 minutes

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.

Trial Locations

Locations (1)

Houston Methodist Hospital

🇺🇸

Houston, Texas, United States

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