Visual Aids for Induction of Labor RCT (VAIL)

September 18, 2024 updated by: Washington University School of Medicine

Visual Aids for Induction of Labor (IOL): A Randomized Controlled Trial for Assessment of Patient IOL Knowledge

This study aims to develop a visual aid tool for induction education informed by the experiences and needs of historically marginalized pregnant women, as well as determine the impact of the patient-informed visual aid on patient knowledge, satisfaction, and trust in physicians regarding induction methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-phased study of patients undergoing IOL. Only the second phase of the study will be detailed in this protocol, as this will be the RCT portion of the study's design. We will test the efficacy of the visual aid by conducting a randomized trial of routine counseling versus counseling with the use of a visual aid (informed by patient interviews in the first phase) at the time of admission for IOL and studying the effect of the visual aid on patient knowledge, trust in providers, and satisfaction.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients scheduled for or admitted for induction of labor and who can speak, read, and write in the English language.

Exclusion Criteria:

  • Patients undergoing induction termination or with a history of prior cesarean section, major fetal anomaly, known chromosomal anomaly, or fetal growth restriction with doppler abnormalities. Patients whose induction has already commenced will also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard counseling
Standard induction of labor counseling
Experimental: Visual aid counseling
Counseling on induction of labor with either a video or a handout
Other: Visual aid
Handout and video describing different types of induction of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction of labor knowledge
Time Frame: 10 minutes (during completion of survey)
Multiple choice questions
10 minutes (during completion of survey)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 10 minutes (during completion of survey)
Likert scale (1-10)
10 minutes (during completion of survey)
Patient trust in providers survey
Time Frame: 10 minutes (during completion of survey)
10 minutes (during completion of survey)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Nandini Raghuraman, MD, MS, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

January 1, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 202301001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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