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Clinical Trials/NCT05127512
NCT05127512
Completed
Not Applicable

Pelvic Floor Disorder Education in the Prenatal Period, a Randomized Controlled Trial

Icahn School of Medicine at Mount Sinai1 site in 1 country94 target enrollmentOctober 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Floor Disorders
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
94
Locations
1
Primary Endpoint
Change in Prolapse and Incontinence Knowledge Questionnaire
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 25, 2021
End Date
May 9, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chandhana Paka

Assistant Professor

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Prolapse and Incontinence Knowledge Questionnaire

Time Frame: 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.

Study Sites (1)

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