Improved Practices for Pregnancy Complications

Overseen By Simran Dhaliwal Project Coordinator

Age: 18+

Sex: Any

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

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance how healthcare providers deliver care to pregnant and postpartum individuals, emphasizing fairness and quality. It tests a new method, the scale-up implementation approach, to improve the application of safety guidelines for maternal health in Michigan. The trial compares current services with this new method to determine which is more effective. Pregnant or postpartum individuals receiving Medicaid in Michigan are included in this study automatically, without direct enrollment. As an unphased trial, it allows participants to contribute to improving healthcare delivery for future patients.

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 this scale-up implementation approach is safe for maternal health equity?

Research has shown that expanding certain methods to improve maternal health is generally safe in community care settings. Studies have tested similar approaches to enhance maternal health and found them well-received. For instance, one study examined safety measures for issues like heavy bleeding during childbirth and high blood pressure, major risks during pregnancy. This study reported no significant negative effects from the approach itself.

The research aims to improve maternal care by sharing best practices, and these methods have been tested in various settings without safety problems directly linked to the approach. Although specific data on negative effects solely from this strategy is lacking, the absence of negative outcomes in related studies suggests it is a safe way to improve maternal health practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Scale-up implementation approach" for pregnancy complications because it focuses on enhancing maternal health equity across community care settings. Unlike standard care options that may not specifically address health disparities, this approach is co-developed with partners to implement bundled, equity-focused safety guidelines county-wide. This method aims to ensure more consistent and accessible maternal health care, potentially reducing complications and improving outcomes for all mothers, especially those in underserved communities.

What evidence suggests that this trial's treatments could be effective for improving maternal health equity?

Research has shown that expanding successful health programs can improve maternal health. Studies in Niger and Mali found that this approach led to better postpartum care and increased adherence to health guidelines among mothers. In the current trial, participants will join one of two groups: the "Scale-up implementation approach," which aims to reduce complications through proven health practices, or "Services as usual," which serves as a comparison. The trial in Michigan addresses differences in pregnancy-related health outcomes, ensuring all mothers receive the same high standard of care. ^{1 3 4 6 7}

Who Is on the Research Team?

Jennifer E. Johnson, Ph.D.

Principal Investigator

Michigan State University

Jaye Clement, MPH, MPP

Principal Investigator

Henry Ford Health

Amy Loree, PhD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

This trial is for prenatal and postnatal care providers in 12 Michigan counties. It aims to improve maternal health equity, but specific eligibility criteria are not provided.

Inclusion Criteria

Provider must be a provider or staff person at agencies offering prenatal and/or postnatal services in Wayne, Oakland, Ingham, Isabella, Macomb, Muskegon, Calhoun, Jackson, Saginaw, Kalamazoo, Barrien, or Washtenaw counties in Michigan

All pregnant or postpartum (up to 12 months) people receiving Medicaid in Michigan

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Development and testing of a scale-up focused implementation approach for addressing PRAMM disparities in community care settings

6 years

Annual assessments

Follow-up

Participants are monitored for safety and effectiveness after implementation

12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Scale-up implementation approach
• Services as usual

Trial Overview The study compares the effectiveness of a 'scale-up implementation approach' to enhance maternal health practices versus continuing with standard services as usual.

How Is the Trial Designed?

Group I: Scale-up implementation approach Experimental Treatment 1 Intervention

An implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners.

Group II: Services as usual Active Control 1 Intervention

Services as usual before maternal health equity implementation efforts

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a review of 6579 medical records from New Zealand public hospitals in 1998, 12.9% of hospital admissions were associated with an adverse event, indicating a significant occurrence of safety issues in acute care settings.

Most adverse events had minor impacts on patients, with less than 15% leading to permanent disability or death, but they significantly increased hospital stays by an average of over nine days, highlighting the need for improved patient safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in New Zealand public hospitals I: occurrence and impact. Davis, P., Lay-Yee, R., Briant, R., et al.[2022]

A multifaceted intervention program in 95 French maternity units led to a significant reduction in suboptimal care for morbidity cases (7.6% vs. 11.5%) and a decrease in the overall incidence of perinatal morbidity (7.0 vs. 8.1‰).

However, the intervention did not significantly lower the combined rate of suboptimal care for morbidity and mortality cases, indicating that further improvements in mortality outcomes may require longer study durations and additional support structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial. Dupont, C., Winer, N., Rabilloud, M., et al.[2018]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

Adverse drug events (ADE) are being considered as a primary metric for evaluating improvements in medication safety in New Zealand public hospitals, but there are challenges in determining the best measures to use.

A multi-stakeholder approach is necessary to develop a comprehensive framework for assessing medication safety, reflecting the need for collaboration among clinicians, policymakers, and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting the foundations right for the measurement of medication safety: the need for a meaningful conceptual frame. Ng, J., Scahill, S., Harrison, J.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11843809/

A cluster randomized stepped wedge implementation trial ... This paper describes the first study to develop and test a scale-up focused implementation approach for maternal health equity. This ...

2. nature.com nature.com/articles/s41591-023-02311-w

A simulation-based comparative effectiveness analysis of ... We used the empirically calibrated Global Maternal Health microsimulation model, which simulates individual women in 200 countries and territories.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39980059/

associated morbidity and mortality disparities in 12 Michigan ... A cluster randomized stepped wedge implementation trial of scale-up approaches to ending pregnancy-related and -associated morbidity and mortality disparities ...

4. withpower.com withpower.com/trial/phase-4-maternal-death-10-2024-27df1

Improved Practices for Pregnancy Complications The research shows that scale-up implementation approaches have been effective in improving postpartum care in Niger and Mali, leading to better compliance ...

5. link.springer.com link.springer.com/content/pdf/10.1186/s43058-024-00677-7.pdf

A cluster randomized stepped wedge implementation trial ... This trial is the first study to develop and test a scale- up focused implementation approach for maternal health equity bundles. Several methodological ...

6. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07896-3

Evaluating the implementation of maternal safety bundles for ... This study examined the implementation of obstetric hemorrhage and severe hypertension safety bundles in Arkansas hospitals, identifying factors ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2214109X24005126

Advancing maternal and perinatal health through clinical ... This paper aims to summarise obstacles and suggest opportunities for appropriate inclusion of pregnant and lactating women in clinical trials.