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Birth; InducedIGNITE-IOLNCT07547657

Implementation Guided by aN Iterative, adapTivE Strategy - Induction of Labor

A study testing BASE, LEAD and TEAM in people with Birth; Induced, run by University of Michigan at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Birth; Induced
What is being tested?
BASE, LEAD and TEAM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
12 Jun 2026to Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: 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.

Conditions
Birth; Induced
Being tested
BASE, LEAD, TEAM
Keywords
Quality improvement, adaptive intervention, sequential multiple assignment randomized trial (SMART)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BASEBehavioural

    BASE (low-intensity, training and reporting, delivered virtually)

  • LEADBehavioural

    LEAD (moderate-intensity, Quality Improvement (QI) leader-focused, delivered virtually)

  • TEAMBehavioural

    TEAM (very high-intensity, clinician-focused, delivered in-person)

Study groups in NCT07547657
Study groupRoleWhat they receive
BASE onlyActive comparatorThe 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.
Receives: Behavioral: BASE
BASE + TEAMExperimentalBASE + 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.
Receives: Behavioral: BASE; Behavioral: TEAM
BASE + LEADExperimentalBASE + 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.
Receives: Behavioral: BASE; Behavioral: LEAD
BASE + LEAD + TEAMExperimentalBASE + 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.
Receives: Behavioral: BASE; Behavioral: LEAD; Behavioral: TEAM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Provider-level adherence to evidence-based IOL

    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.

    Measured: Up to 30 months

Secondary outcomes (6)

  1. Adherence to evidence-based induction technique 1 (dual-agent cervical ripening)

    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.

    Measured: Up to 30 months

  2. Adherence to technique 2 (early amniotomy)

    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.

    Measured: Up to 30 months

  3. Median time induction to birth

    Average time, in hours, between induction start time and time of birth

    Measured: Up to 30 months

  4. Percent delivery within 24 hours

    Proportion of patients undergoing induction who deliver within 24 hours of induction start

    Measured: Up to 30 Months

  5. Median time induction to membrane rupture

    Average time, in hours, from induction start to time of rupture of membranes

    Measured: Up to 30 Months

  6. Median time from rupture of membranes to birth

    Average time, in hours, from time of rupture of membranes to time of birth

    Measured: Up to 30 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start12 Jun 2026
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Sequential
Model description
This is a clustered, Sequential, Multiple Assignment Randomized Trial (SMART), with up to 64 hospital members of the Obstetrics Initiative (OBI) (see Figure 1). The unit of randomization will be the hospital. Time is measured in months since the onset of Stage 1, when all hospitals are offered BASE. The first randomization-to LEAD vs no LEAD with equal probability-occurs at the beginning of Month 6 (Stage 2). Subsequent randomizations-to TEAM vs no TEAM (Stage 3) with equal probability-occur at the beginning of Month 13, among non-Top Performer hospitals. This SMART will address how best to sequence different strategies across a population, informing the construction of an optimized, three-stage, 30-month adaptive implementation strategy for adherence to evidence-based IOL. This study is a clustered SMART because the sequential randomizations (e.g., to LEAD, to TEAM) are at the hospital level, while the outcome is at the level of providers nested within hospitals.
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547657
Sponsor's protocol ID
HUM00288513
Acronym
IGNITE-IOL
Status last verified
Jul 2026
First submitted
16 Apr 2026
Last updated
10 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Moniz MH, Stout MJ, Triebwasser JE, Low LK, Hamm R, Simpson C, Chen X, Ems J, Kilbourne A, Hutton D, Englesbe M, Almirall D. Protocol for a sequentially randomized trial to optimize an adaptive implementation strategy to promote evidence-based management of induction of labor: the IGNITE-IOL trial. Implement Sci. 2026 Jul 29;21(1):62. doi: 10.1186/s13012-026-01525-z.

    PubMed 42934688

Questions about this trial

What is this clinical trial studying?

A study testing BASE, LEAD and TEAM in people with Birth; Induced, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Provider-level adherence to evidence-based IOL (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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