Should I Have an Elective Induction?

NCT05838313 | Completed Results

• 2 other identifiers: STUDY004944R21HD098496
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of the proposed study is to perform a pilot test of a patient-centered decision support tool to help pregnant people and providers work together in making informed, shared decisions regarding whether or not to opt for elective IOL at 39 weeks gestation

Conditions

Labor, Induced; Patient Preference

Keywords

Shared Decision Making

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate

  Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study

  32-38 weeks gestation

• Proportion of People Completely Viewing the Decision Support Tool

  The proportion of participants who view all of the pages of the decision support tool will be calculated

  36-38 weeks gestation

Secondary Outcomes (3)

• Satisfaction With the Decision Support Tool

  36-38 weeks gestation

• Satisfaction With the Decision Support Tool

  38-39 weeks gestation, prior to delivery

• Impact of App on Decision Making

  2-4 weeks Postpartum

Study Arms (1)

Decision Support Tool

EXPERIMENTAL

Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication

Behavioral: Elective Induction of Labor Decision Support Tool

Interventions

Elective Induction of Labor Decision Support Tool BEHAVIORAL

Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor

Decision Support Tool

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant person
• Nulliparous
• Planned vaginal delivery
• No medical indication for induction of labor

You may not qualify if:

• Contraindication to vaginal delivery
• Prior delivery (vaginal or cesarean)
• Medical indication for induction of labor

Sponsors & Collaborators

• University of South Florida: lead
• Ohio State University: collaborator
• University of California, San Francisco: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of South Florida

Tampa, Florida, 33606, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Anjali Kaimal, MD, MAS
• Organization: University of South Florida Morsani College of Medicine, Department of Obstetrics and Gynecology

akaimal@usf.edu

(813) 259-8680

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: May 1, 2023
• Study Start: March 22, 2023
• Primary Completion: August 7, 2023
• Study Completion: September 30, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Locations

US (2)