Adaptive Strategies for Induced Birth
(IGNITE-IOL Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1: BASE
Hospitals receive BASE intervention to improve induction management
Stage 2: BASE + LEAD
All hospitals receive LEAD in addition to BASE to enhance adherence to evidence-based practices
Stage 3: BASE + LEAD + TEAM
Non-Top Performer hospitals receive TEAM in addition to BASE and LEAD; Top Performer hospitals continue with BASE + LEAD
Follow-up
Participants are monitored for adherence to evidence-based practices and clinical outcomes
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
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
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 ...
2.
evidencebasedbirth.com
evidencebasedbirth.com/evidence-on-inducing-labor-for-going-past-your-due-date/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 [ ...
6.
michiganmedicine.org
michiganmedicine.org/health-lab/labor-induction-doesnt-always-reduce-caesarean-birth-risk-or-improve-outcomes-term-pregnanciesLabor 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 ...
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