Should I Have an Elective Induction?

Not Applicable

Completed

• Conditions: Patient Preference; Labor, Induced

• Registration Number: NCT05838313
• Lead Sponsor: University of South Florida

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

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 Timeline

• Study First Submitted: 2022-12-13
• Study Start: 2023-03-22
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-01
• Primary Completion: 2023-08-07
• Study Completion: 2023-09-30
• Results First Submitted: 2024-12-05
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Results First Posted: 2025-01-14
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of People Completely Viewing the Decision Support Tool	36-38 weeks gestation	The proportion of participants who view all of the pages of the decision support tool will be calculated
Recruitment Rate	32-38 weeks gestation	Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of South Florida; 🇺🇸 Tampa, Florida, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States