Pelvic Floor Disorder Education in Prenatal Care

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT05127512
Collaborator
(none)
94
1
2
6.4
14.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Education Video
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pelvic Floor Disorder Education in the Prenatal Period, a Randomized Controlled Trial
Actual Study Start Date :
Oct 25, 2021
Actual Primary Completion Date :
May 9, 2022
Actual Study Completion Date :
May 9, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

Control participants will only complete the knowledge questionnaire in addition to a non-validated survey created by the investigators to collect demographic information as well as attitudes towards treatments of pelvic floor disorders.

Experimental: Video Group

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

Other: Education Video
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Icahn School of Medicine at Mount Sinai New York New York United States 10029

Sponsors and Collaborators

  • Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Chandhu Paka, MD, Mount Sinai West

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chandhana Paka, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT05127512
Other Study ID Numbers:
  • STUDY-20-03435
First Posted:
Nov 19, 2021
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Chandhana Paka, Assistant Professor, Icahn School of Medicine at Mount Sinai
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022