Multilevel Intervention for Maternal Health Equity

(MIRACLE Trial)

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Michigan State University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce health issues and deaths among African American mothers in Genesee and Kent counties, Michigan. Researchers will test a program called a multilevel intervention, which involves communities, healthcare providers, and systems to address racial disparities in maternal health. The trial will use data from women insured by Medicaid who gave birth in Michigan between 2016–2019 and 2022–2025. Women who gave birth while living in Kent or Genesee County might be a good fit for this trial. As an unphased trial, participants can contribute to groundbreaking research that seeks to improve maternal health outcomes in their communities.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this multilevel intervention is safe for reducing maternal morbidity and mortality disparities?

Research has shown that various strategies have addressed differences in maternal health care. However, specific safety information for this new approach aimed at improving African American maternal health in Michigan remains limited. This study is among the first to examine these strategies for serious health issues during and after childbirth.

This is not a typical clinical trial involving a new drug or medical device, so the safety concerns differ. The study focuses on improving care at the community, provider, and system levels. These strategies are generally safe because they involve changing how care is delivered and adding support, rather than introducing new medicines or procedures.

For those considering participation, it's important to understand that the risks involve changes in healthcare delivery, not direct health risks from a treatment. Participants should feel comfortable asking questions and discussing any concerns with the study coordinators to understand how the study might affect their care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multilevel intervention for maternal health equity because it aims to tackle racial disparities in severe maternal morbidity and mortality through a comprehensive approach. Unlike traditional treatments that might focus solely on medical care, this intervention considers the broader social factors affecting maternal health, such as access to resources and community support. By implementing strategies at multiple levels, including community and healthcare system changes, this approach seeks to create a more equitable environment for maternal health outcomes.

What evidence suggests that this trial's multilevel intervention could be effective for reducing racial disparities in maternal morbidity and mortality?

This trial will compare a multilevel intervention for racial disparities in severe maternal morbidity and mortality with Standard Enhanced Prenatal Care (EPC) services. Research has shown that using multiple strategies can help reduce racial differences in serious health problems and deaths related to pregnancy and childbirth. These strategies address issues at various levels, such as personal, community, and healthcare systems. Studies have found that these methods can improve health for African American women during and after pregnancy. By enhancing prenatal care and community support, these strategies aim to reduce complications and deaths among African American mothers. Early results suggest these approaches are promising in reducing health disparities in certain Michigan communities. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer E Johnson, PhD

Principal Investigator

Michigan State University

Cristian Meghea, PhD

Principal Investigator

Michigan State University

Are You a Good Fit for This Trial?

The MIRACLE Project is for African American women who gave birth in Genesee or Kent counties, Michigan during specific periods (2016-2019 and 2022-2025) and were covered by Medicaid. There are no exclusion criteria, so all women from these areas and times can participate.

Inclusion Criteria

Resided in intervention county at time of delivery

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of multilevel interventions at community, provider, and system levels to address maternal morbidity and mortality disparities

3 years

Follow-up

Participants are monitored for outcomes such as severe maternal morbidity and pregnancy-related mortality up to 1 year postpartum

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Multilevel intervention for racial disparities in severe maternal morbidity and mortality
• Standard Enhanced Prenatal Care (EPC) services

Trial Overview This study compares a multilevel intervention aimed at reducing racial disparities in severe maternal morbidity and mortality against standard enhanced prenatal care services provided to African American mothers in the selected Michigan counties.

How Is the Trial Designed?

Group I: Intervention counties Experimental Treatment 2 Interventions

Birthing persons who live in Kent County or Genesee County, Michigan, USA at the time of delivery.

Group II: Control counties Active Control 1 Intervention

Birthing persons who live in the other Michigan, USA counties at the time of delivery.

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Hurley Medical Center

Collaborator

Trials

7

Recruited

544,000+

Ascension Health

Industry Sponsor

Trials

28

Recruited

543,000+

Spectrum Health Hospitals

Collaborator

Trials

66

Recruited

553,000+

Hurley MIHP and Healthy Start

Collaborator

Trials

1

Recruited

540,000+

Ascension MIHP and Healthy Start

Collaborator

Trials

1

Recruited

540,000+

Genesee County Health Department

Collaborator

Trials

1

Recruited

540,000+

Community Based Organization Partners

Collaborator

Trials

1

Recruited

540,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10263288

Meeting women where they are - NIH RePORTER This proposal will test the effectiveness and cost-effectiveness of a multilevel intervention to address AA maternal morbidity and mortality in two Michigan ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05386316

The Maternal Health Multilevel Intervention for Racial ... Assess the effectiveness of the multilevel intervention on the following outcomes: AA SMM and pregnancy-related mortality (up to 1-year postpartum; overall & ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422002208

Study protocol: The Maternal Health Multilevel Intervention ... This study is among the first to examine effects of any multilevel intervention on AA severe maternal morbidity and mortality.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9809987/

Study protocol: The Maternal Health Multilevel Intervention ... The MIRACLE project tests a multilevel intervention to reduce African American severe maternal morbidity and mortality, using enhanced prenatal ...

5. app.dimensions.ai app.dimensions.ai/details/grant/grant.9412456

Multilevel intervention addressing racial disparities in ... This proposal will test the effectiveness and cost-effectiveness of a multilevel intervention to address AA maternal morbidity and mortality in two Michigan ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/12/6/e062294

Multilevel determinants of racial/ethnic disparities in severe ... The overarching goal of this study is to investigate racial/ethnic disparities in SMMM, the contributing roles and mediating pathways of social contexts (eg, ...