Should I Have an Elective Induction? (SELECTION)

Should I Have an Elective Induction? The SELECTION Study

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

Study Overview

• Status: Completed
• Conditions: Labor, Induced; Patient Preference
• Intervention / Treatment: Behavioral: Elective Induction of Labor Decision Support Tool

Detailed Description

60 nulliparous pregnant people with singleton, vertex pregnancies at 36-38 weeks who do not have an indication for induction of labor (IOL) will be enrolled and will view a decision support tool (DST) regarding induction without medical indication. During the enrollment face-to-face interview, participants will interact with the DST and complete pre- and post-DST viewing questionnaires. The investigators will conduct telephone interviews a few days later but before 39+0 weeks, and again 2-4 weeks postpartum and will review the medical record for delivery events and outcomes.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • University Of South Florida
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decision Support Tool; 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; Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction With the Decision Support Tool	4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.	36-38 weeks gestation
Satisfaction With the Decision Support Tool	4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.	38-39 weeks gestation, prior to delivery
Impact of App on Decision Making	5 point scale (Strongly disagree to Strongly agree, 5=Strongly agree) "Viewing the App affected my decision making"	2-4 weeks Postpartum

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Shared Decision Making
• Other Study ID Numbers: STUDY004944; R21HD098496 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No