SELECTION: Should I Have an Elective Induction?

• Sponsor: University of South Florida (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05838313
• Collaborator: Ohio State University (Other), University of California, San Francisco (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 60
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 8.3
• Patients Per Site: 30
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Labor, Induced; Patient Preference	Behavioral: Elective Induction of Labor Decision Support Tool	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Should I Have an Elective Induction? The SELECTION Study
• Actual Study Start Date: Mar 22, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. Satisfaction with the Decision Support Tool [Date of first patient approached to last patient enrolled, assessed up to 52 weeks]

   4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.

2. 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.

3. Satisfaction with the Decision Support Tool [2-4 weeks Postpartum]

   4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Florida	Tampa	Florida	United States	33606
2	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT05838313
• Other Study ID Numbers: STUDY004944; R21HD098496
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of South Florida: Shared Decision Making

Study Results

No Results Posted as of May 1, 2023