NCT05440539

Educating Women About Pelvic Floor Disorders During Pregnancy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pelvic Floor Disorders
• Stress Urinary Incontinence
• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	Written Handouts	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.
OTHER	Interactive Workshop	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.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-05-05
• Completion: 2021-09-10
• First posted: 2022-07-01
• Last updated: 2025-06-19
• Results posted: 2025-06-19

Locations

1 site across 1 country: United States