Implementation Guided by aN Iterative, adapTivE Strategy - Induction of Labor (IGNITE-IOL)

April 16, 2026 updated by: Michelle H. Moniz, University of Michigan

Protocol for a Sequential Multiple-Assignment Randomized Trial to Optimize an Adaptive Intervention to Promote Evidence-based Management of Induction of Labor: the IGNITE-IOL Trial

This trial is designed to investigate how best to support hospitals in improving induction management and clinical outcomes. The researchers will investigate an adaptive implementation strategy designed to support hospitals in increasing adherence to evidence-based practices for induction of labor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Michelle Moniz, MD, MSc

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Maternity Clinicians (Individuals implementing QI initiatives on participating maternity units, all bedside clinicians on these units, and any other hospital employees identified by OBI champions as relevant to include, will be eligible to attend LEAD and TEAM activities.)

Exclusion Criteria:

  • Individuals not working on these units are ineligible, which will exclude children under the age of 18 and retired, older adults.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: BASE only

The BASE only comparator (control arm) starts with BASE in Stage 1, continues with BASE in Stage 2, and continues with BASE in Stage 3, regardless of Top Performer status.

The BASE only arm is defined as the hospitals that get solely BASE (and nothing more) for 30 months.
Behavioral: BASE
BASE (low-intensity, training and reporting, delivered virtually)
Experimental: BASE + TEAM
BASE + TEAM starts with BASE in Stage 1, continues BASE in Stage 2, continues BASE in Stage 3 for Top Performer hospitals, and adds TEAM in Stage 3 for non-Top Performer hospitals. This arm does not offer LEAD.
Behavioral: BASE
BASE (low-intensity, training and reporting, delivered virtually)
Behavioral: TEAM
TEAM (very high-intensity, clinician-focused, delivered in-person)
Experimental: BASE + LEAD
BASE + LEAD starts with BASE in Stage 1, adds LEAD in Stage 2 for all hospitals, and continues BASE + LEAD in Stage 3 for all hospitals. This arm does not offer TEAM.
Behavioral: BASE
BASE (low-intensity, training and reporting, delivered virtually)
Behavioral: LEAD
LEAD (moderate-intensity, Quality Improvement (QI) leader-focused, delivered virtually)
Experimental: BASE + LEAD + TEAM
BASE + LEAD + TEAM starts with BASE in Stage 1. In Stage 2, all hospitals are offered LEAD. In Stage 3, Top Performing hospitals continue BASE + LEAD, while non-Top Performing hospitals step up to TEAM in addition to BASE and LEAD. This is considered the most intensive of the four embedded implementation strategies.
Behavioral: BASE
BASE (low-intensity, training and reporting, delivered virtually)
Behavioral: TEAM
TEAM (very high-intensity, clinician-focused, delivered in-person)
Behavioral: LEAD
LEAD (moderate-intensity, Quality Improvement (QI) leader-focused, delivered virtually)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Provider-level adherence to evidence-based IOL
Time Frame: Up to 30 months
Defined as a percentage where the numerator = past month total number of evidence-based IOL techniques offered (regardless of whether they were completed, attempted unsuccessfully, or declined by the patient); and the denominator = past month total number of eligible opportunities to offer any evidence-based IOL technique. Data will be attributed at the individual provider level and analyzed at the provider level for the primary outcome. These data may also be aggregated at the hospital level-e.g., when examining whether % evidence-based IOL adherence at the hospital level is a moderator of the effects of LEAD and TEAM.
Up to 30 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to evidence-based induction technique 1 (dual-agent cervical ripening)
Time Frame: Up to 30 months
defined as a percentage where the numerator = past month total number of offers of dual-agent cervical ripening (regardless of whether they were completed, attempted unsuccessfully, or declined by the patient); and the denominator = past month total number of eligible opportunities to offer dual-agent cervical ripening. Data will be attributed at the individual provider level and analyzed at the provider level for the secondary outcome.
Up to 30 months
Adherence to technique 2 (early amniotomy)
Time Frame: Up to 30 months
Defined as a percentage where the numerator = past month total number of offers of early amniotomy (regardless of whether they were completed, attempted unsuccessfully, or declined by the patient); and the denominator = past month total number of eligible opportunities to offer early amniotomy. Data will be attributed at the individual provider level and analyzed at the provider level for the secondary outcome.
Up to 30 months
Median time induction to birth
Time Frame: Up to 30 months
Average time, in hours, between induction start time and time of birth
Up to 30 months
Percent delivery within 24 hours
Time Frame: Up to 30 Months
Proportion of patients undergoing induction who deliver within 24 hours of induction start
Up to 30 Months
Median time induction to membrane rupture
Time Frame: Up to 30 Months
Average time, in hours, from induction start to time of rupture of membranes
Up to 30 Months
Median time from rupture of membranes to birth
Time Frame: Up to 30 Months
Average time, in hours, from time of rupture of membranes to time of birth
Up to 30 Months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle Moniz, MD, MSc, University of Michigan

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00288513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data generated in this study will be stored and archived in HIPAA-compliant Turbo drives at the University of Michigan. Turbo is a high-capacity, high-performance network storage solution, providing secure and reliable data storage to researchers across the University of Michigan. Due to OBI's existing Data Use Agreements with hospitals, the researchers will not be able to share data in an open repository.

IPD Sharing Time Frame

The data will be made available to other researchers, as soon as possible after a Data Use Agreement is executed with an interested party and OBI, in accordance with OBI Coordinating Center policy and OBI's existing Data Use Agreements with its member hospitals. To provide access to deidentified data from human subjects, the researchers will verify that the data receiver has met all necessary regulatory requirements (e.g., IRB approval, data use agreements, etc.)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

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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