Should I Have an Elective Induction? The SELECTION Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of South Florida
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Proportion of People Completely Viewing the Decision Support Tool
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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
Arms & Interventions
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
Intervention: Elective Induction of Labor Decision Support Tool (Behavioral)
Outcomes
Primary Outcomes
Proportion of People Completely Viewing the Decision Support Tool
Time Frame: 36-38 weeks gestation
The proportion of participants who view all of the pages of the decision support tool will be calculated
Recruitment Rate
Time Frame: 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 Outcomes
- Satisfaction With the Decision Support Tool(38-39 weeks gestation, prior to delivery)
- Impact of App on Decision Making(2-4 weeks Postpartum)
- Satisfaction With the Decision Support Tool(36-38 weeks gestation)