Pelvic Floor Disorder Education in Prenatal Care

NCT ID: NCT05127512

Last Updated: 2022-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2022-05-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Floor Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Video Group

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

Group Type EXPERIMENTAL

Education Video

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chandhana Paka

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chandhu Paka, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai West

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.

Reference Type BACKGROUND
PMID: 24807341 (View on PubMed)

Hyakutake MT, Han V, Cundiff GW, Baerg L, Koenig NA, Lee T, Geoffrion R. Pelvic Floor Health Education: Can a Workshop Enhance Patient Counseling During Pregnancy? Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):336-9. doi: 10.1097/SPV.0000000000000285.

Reference Type BACKGROUND
PMID: 27171319 (View on PubMed)

Geoffrion R, Robert M, Ross S, van Heerden D, Neustaedter G, Tang S, Milne J. Evaluating patient learning after an educational program for women with incontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Oct;20(10):1243-52. doi: 10.1007/s00192-009-0919-5. Epub 2009 Jun 11.

Reference Type BACKGROUND
PMID: 19517050 (View on PubMed)

Howell EA. Lack of patient preparation for the postpartum period and patients' satisfaction with their obstetric clinicians. Obstet Gynecol. 2010 Feb;115(2 Pt 1):284-289. doi: 10.1097/AOG.0b013e3181c8b39b.

Reference Type BACKGROUND
PMID: 20093900 (View on PubMed)

Liu J, Tan SQ, Han HC. Knowledge of pelvic floor disorder in pregnancy. Int Urogynecol J. 2019 Jun;30(6):991-1001. doi: 10.1007/s00192-019-03891-3. Epub 2019 Feb 19.

Reference Type BACKGROUND
PMID: 30783706 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY-20-03435

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Postpartum Pelvic Floor Workshop
NCT04754984 COMPLETED NA