Should I Have an Elective Induction?

NCT ID: NCT05838313

Last Updated: 2025-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2023-09-30

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.

Conditions

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Labor, Induced Patient Preference

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Elective Induction of Labor Decision Support Tool

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of South Florida

Tampa, Florida, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY004944

Identifier Type: -

Identifier Source: org_study_id

R21HD098496

Identifier Type: NIH

Identifier Source: secondary_id

View Link

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