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 aims to help hospitals improve the management of labor induction, the process of starting childbirth artificially. Researchers are testing various strategies to determine which best supports hospitals in implementing evidence-based practices, which are proven methods based on research. The trial includes four groups, each receiving different combinations of support strategies: BASE only, BASE + TEAM, BASE + LEAD, and BASE + LEAD + TEAM. Maternity clinicians working in participating hospital units and involved in quality improvement initiatives are sought for this trial.

As an unphased trial, this study provides a unique opportunity to enhance hospital practices and patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these adaptive strategies for induced birth are safe?

Previous studies have shown mixed safety results for inducing labor. Research on treatments like BASE + TEAM suggests that inducing labor can sometimes lead to more medical procedures, increasing risks for mothers and babies. However, some babies in induction groups experienced fewer severe problems compared to those who waited for natural labor.

For BASE + LEAD, studies have shown similar results. Inducing labor can help avoid cesarean deliveries (C-sections) in some cases, but it doesn't always reduce them. There is also a chance of more medical procedures and possible complications, though many women reach active labor within hours.

The BASE + LEAD + TEAM approach emphasizes teamwork and communication, which might improve decision-making during labor. However, like the other treatments, there is a link between induction and more medical procedures, potentially leading to increased risks.

Overall, while inducing labor offers some benefits, it may also increase the likelihood of medical procedures and complications. These factors are important to consider when deciding to join a trial involving labor induction methods.12345

Why are researchers excited about this trial?

Researchers are excited about the Adaptive Strategies for Induced Birth trial because it explores innovative ways to optimize childbirth processes. Unlike standard induction methods, like using oxytocin or prostaglandins alone, this trial tests combinations of strategies (BASE, LEAD, and TEAM) to enhance outcomes. The BASE + LEAD + TEAM approach, for instance, tailors the intensity of intervention based on hospital performance, potentially offering a more personalized and effective induction strategy. By adapting to hospital performance, these strategies aim to improve safety and efficiency in induced births, providing insights that could revolutionize current practices.

What evidence suggests that this trial's treatments could be effective for improving induction management?

Research has shown that various methods to initiate labor can be effective. In this trial, participants may receive different treatment strategies. For those in the BASE + TEAM arm, one study found that 65.5% of participants began active labor within 6 hours, and 96.4% did so within 15 hours. The BASE + LEAD arm has been associated with fewer C-sections, as a review of studies found that certain induction methods reduced the likelihood of needing one. Using a combination of BASE + LEAD + TEAM, another arm in this trial, with a set care plan improved delivery times and outcomes. These findings suggest that these strategies can effectively manage labor induction and lead to better results.12367

Who Is on the Research Team?

MM

Michelle Moniz, MD, MSc

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for maternity clinicians and hospital staff who work on specific maternity units involved in quality improvement for labor induction. It does not include people under 18, retired adults, or anyone not working on these units.

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

Trial Overview

The study is testing different ways (BASE, LEAD, TEAM) to help hospitals follow best practices when inducing labor. The goal is to find the most effective support strategy using an adaptive approach across participating hospitals.

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+

Citations

Review of Evidence-Based Methods for Successful Labor ...

That study found that 65.5% of the participants reached active labor by 6 hours and 96.4% achieved active labor after a 15-hour latent phase. Although maternal ...

Evidence on: Inducing for Due Dates

In the expectant management group, 74% of the participants went into labor spontaneously before their planned induction and 26% were induced. Interestingly, the ...

Standardized protocol for labor induction: a type I hybrid ...

The primary effectiveness outcome was cesarean delivery. Secondary effectiveness outcomes included labor length, chorioamnionitis, and maternal ...

Trends in the use of induction of labor by methods and ... - PMC

Induction of labor rates increased significantly from 25.4% in 2012 to 37.7% in 2020, with a notable rise at 38 and 39 weeks' gestation.

Methods for the induction of labor: efficacy and safety

A meta-analysis of the first 8 trials found that labor induction with vaginal misoprostol significantly reduced the incidence of cesarean delivery (odds ratio [ ...

Labor induction doesn't always reduce caesarean birth risk or ...

A new study suggests that inducing labor at 39 weeks for low-risk pregnancies may not reduce the risk of C-sections or improve outcomes.

Quality-Improvement Strategies for Safe Reduction of ...

A focus on promoting safe vaginal birth through evidence-based practices and QI strategies to safely reduce a patient's first cesarean birth ...