Should I Have an Elective Induction?

Not Applicable

Completed

• Conditions: Patient Preference; Labor, Induced
• Interventions: Behavioral: Elective Induction of Labor Decision Support Tool

• 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
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

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

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decision Support Tool	Elective Induction of Labor 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

Primary Outcome Measures

Name	Time	Method
Recruitment rate	Date of first patient approached to last patient enrolled, assessed up to 52 weeks	Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study
Proportion of people completing the Decision Support Tool	Date of first patient approached to last patient enrolled, assessed up to 52 weeks	The proportion of participants who view all of the pages of the decision support tool will be calculated

Secondary Outcome Measures

Name	Time	Method
Satisfaction with the Decision Support Tool	2-4 weeks Postpartum	4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.

Trial Locations

Locations (2)

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

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