Visual Aids for Induction of Labor RCT

Not Applicable

Recruiting

• Conditions: Induced; Birth
• Interventions: Other: Visual aid

• Registration Number: NCT05671224
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-04
• Study Start: 2023-03-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Visual aid counseling	Visual aid	Counseling on induction of labor with either a video or a handout

Primary Outcome Measures

Name	Time	Method
Induction of labor knowledge	10 minutes (during completion of survey)	Multiple choice questions

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	10 minutes (during completion of survey)	Likert scale (1-10)
Patient trust in providers survey	10 minutes (during completion of survey)

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States