Should I Have an Elective Induction?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Should I Have an Elective Induction? The SELECTION Study

Conditions
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Labor, Induced, Patient Preference

Intervention / Treatment
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* Behavioral: Elective Induction of Labor Decision Support Tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Support Tool<br>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<br>* Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Satisfaction with the Decision Support Tool | 4 item scale. Range of 0-20, with higher scores indicating higher satisfaction. | 2-4 weeks Postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shared Decision Making