Should I Have an Elective Induction? (SELECTION)

October 12, 2023 updated by: University of South Florida

Should I Have an Elective Induction? The SELECTION Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: USF OBGYN Clinical Research
  • Phone Number: (813) 259- 0655
  • Email: akaimal@usf.edu

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 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
Date of first patient approached to last patient enrolled, assessed up to 52 weeks
Proportion of people completing the Decision Support Tool
Time Frame: 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
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
Time Frame: 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.
Date of first patient approached to last patient enrolled, assessed up to 52 weeks
Satisfaction with the Decision Support Tool
Time Frame: 38-39 weeks gestation, prior to delivery
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
Time Frame: 2-4 weeks Postpartum
4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.
2-4 weeks Postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2023

Primary Completion (Actual)

August 7, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY004944
  • R21HD098496 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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