Pelvic Floor Disorder Education in Prenatal Care

Not Applicable

Completed

• Conditions: Pelvic Floor Disorders
• Interventions: Other: Education Video

• Registration Number: NCT05127512
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Pelvic floor disorders (PFDs) are common conditions that can have significant impacts on patients' quality of life and psychosocial well-being. It is well known that patients who have experienced pregnancy and childbirth are at risk of developing these conditions, either during pregnancy, postpartum, or later in life. However, many women are unaware of this predisposing risk factor. Additionally, overall knowledge of these conditions is low in both the general and obstetrics population.

Video education has been used in various fields with success in improving patient knowledge of specific topics and conditions. To the researchers' knowledge, no studies have evaluated this modality for educating obstetrics patients on PFDs. The aim of this study is to determine whether the use of an educational video will improve knowledge of PFDs compared to routine prenatal counseling, using a validated knowledge questionnaire.

Detailed Description

Once verbal consent is obtained, participants will be randomly assigned in a 1:1 ratio to the intervention (video education) or control group (routine prenatal visit only). Group assignments will be performed using computer-generated randomization. All participants will complete a paper questionnaire including basic demographic information, prior history of pelvic floor disorders, and current PFD symptoms. Participants assigned to the routine prenatal visit only will be instructed to complete the Prolapse and Incontinence Knowledge Questionnaire (PIKQ). The PIKQ is a validated 24-item questionnaire designed to assess knowledge of PFDs, including two 12-item subscales on urinary incontinence (PIKQ-UI) and prolapse (PIKQ-POP).

Study Timeline

• Study Start: 2021-10-25
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-11-19
• Status Verified: 2022-05
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

• Women 18 years or older in their third trimester of pregnancy (37 weeks of gestation or greater)
• English-speaking

Exclusion Criteria

• Non-English-speaking patients
• Gestational age < 37 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video Group	Education Video	These participants will be administered the study intervention, which entails viewing an education video on pelvic floor disorders.

Primary Outcome Measures

Name	Time	Method
Change in Prolapse and Incontinence Knowledge Questionnaire	Baseline, 1 day ( the time of enrollment) and at 6-8 weeks	The questionnaire is divided into two separate 12-item subscales on urinary incontinence (PIKQ-UI) and prolapse (PIKQ-POP). Subscales from 0 to 12. Total scale from 0-24. A higher score indicates higher proficiency.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States