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NCT Number: NCT07547657

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Birth; Induced

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

BASE

Behavioral

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

LEAD

Behavioral

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

TEAM

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Median time induction to birth

    Time frame: Up to 30 months

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

  4. Percent delivery within 24 hours

    Time frame: Up to 30 Months

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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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

Acronym: IGNITE-IOL

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Jul 10, 2026

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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