Pelvic Floor Disorder Education in Prenatal Care

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.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

education video

Other

A 6.47-minute education video was created by the research group based on American Urogynecology Society (AUGS) and International Urogynecologic Association (IUGA) patient education pamphlets. Participants in the intervention group will be asked to watch this video after completing a baseline knowledge questionnaire of pelvic floor disorders.

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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Nov 19, 2021
Registry last updated: May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed