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OpenTrials
Completed

NCT Number: NCT05838313

Should I Have an Elective Induction?

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

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Key information

Conditions

Labor, Induced Behavior Health Behavior Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elective Induction of Labor Decision Support Tool

Behavioral

Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Satisfaction With the Decision Support Tool

    Time frame: 36-38 weeks gestation

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

  2. 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.

  3. Impact of App on Decision Making

    Time frame: 2-4 weeks Postpartum

    5 point scale (Strongly disagree to Strongly agree, 5=Strongly agree) "Viewing the App affected my decision making"

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

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

Registry information

Official study title

Should I Have an Elective Induction? The SELECTION Study

Acronym: SELECTION

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 1, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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