Adaptive Strategies for Induced Birth

(IGNITE-IOL Trial)

CS
Overseen ByCarey Simpson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

MM

Michelle Moniz, MD, MSc

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

I am currently working on the required units and am at least 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1: BASE

Hospitals receive BASE intervention to improve induction management

10 months

Stage 2: BASE + LEAD

All hospitals receive LEAD in addition to BASE to enhance adherence to evidence-based practices

10 months

Stage 3: BASE + LEAD + TEAM

Non-Top Performer hospitals receive TEAM in addition to BASE and LEAD; Top Performer hospitals continue with BASE + LEAD

10 months

Follow-up

Participants are monitored for adherence to evidence-based practices and clinical outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BASE
  • LEAD
  • TEAM

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: BASE + TEAMExperimental Treatment2 Interventions
Group II: BASE + LEAD + TEAMExperimental Treatment3 Interventions
Group III: BASE + LEADExperimental Treatment2 Interventions
Group IV: BASE onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+