Should I Have an Elective Induction?

Patient Preference Clinical Trial

— SELECTION  

Official title:

Should I Have an Elective Induction? The SELECTION Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05838313
• Other study ID #: STUDY004944
• Secondary ID: R21HD098496
• Status: Completed
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 30, 2023
• Est. primary completion date: August 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor, Induced
• Patient Preference

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	University of South Florida	Tampa	Florida

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study	Date of first patient approached to last patient enrolled, assessed up to 52 weeks
Primary	Proportion of people completing the Decision Support Tool	The proportion of participants who view all of the pages of the decision support tool will be calculated	Date of first patient approached to last patient enrolled, assessed up to 52 weeks
Secondary	Satisfaction with the Decision Support Tool	4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.	Date of first patient approached to last patient enrolled, assessed up to 52 weeks
Secondary	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
Secondary	Satisfaction with the Decision Support Tool	4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.	2-4 weeks Postpartum