Maternal Safety Interventions for Reducing Severe Maternal Morbidity

Overseen By Ndidiamaka Amutah Onukagha, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Pregnancies under 20 weeks, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

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 improve maternity care for Black women at higher risk of severe complications during pregnancy and childbirth. It will test two main approaches: implementing maternal safety bundles (safety guidelines) at hospitals to manage issues like severe bleeding and high blood pressure, and evaluating the impact of trained doulas (birth coaches) supporting mothers. The trial seeks participants who identify as Black or African American and are receiving community doula support at specific hospitals in Massachusetts. By collecting data from hospitals and interviews, the trial aims to address racial disparities and develop better care practices. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could significantly improve maternity care for Black women.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that these interventions are safe for maternal health?

Research shows that both maternal safety bundles and doula services can improve maternal health. Maternal safety bundles, which are sets of guidelines designed to make childbirth safer, have been found to lower the risk of serious health issues during or after childbirth, particularly for Black women—a key focus of this trial.

Regarding doula services, research suggests that having a doula (a trained support person) during pregnancy and birth can lead to better health outcomes, such as fewer cesarean sections and premature births. Doulas provide emotional and physical support, benefiting both mothers and babies.

Both approaches are generally safe and well-received, with no major side effects commonly associated with these methods. The goal is to enhance current care without introducing new drugs or invasive procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they offer a comprehensive approach to tackling severe maternal morbidity, focusing on both medical and support strategies. The Maternal Safety Bundles Implementation targets critical issues such as obstetric hemorrhage and severe hypertension, with an added emphasis on reducing racial and ethnic disparities. This approach not only leverages proven quality improvement models but also addresses systemic inequities in maternal care. On the other hand, integrating doula services offers personalized support to mothers, with enhanced training ensuring consistency and quality across participating sites. Together, these interventions aim to create a safer and more equitable maternal care environment.

What evidence suggests that these interventions could be effective for reducing severe maternal morbidity?

Research has shown that maternal safety bundles, one of the interventions in this trial, can improve health outcomes for pregnant women. These bundles have been linked to a 42% decrease in eclampsia, a serious condition involving high blood pressure during pregnancy. They also help reduce severe health issues and deaths among mothers, particularly in Black women. Additionally, this trial will evaluate the impact of doula services, another intervention under study. Studies indicate that having a doula, a trained birth companion, can greatly improve birth outcomes. Women with doulas are 47% less likely to have a cesarean section and 29% less likely to give birth early. Both approaches in this trial aim to improve maternal health and lower risks during childbirth. ^{1 2 3 6 7}

Who Is on the Research Team?

Ndidiamaka Amutah Onukagha, PhD

Principal Investigator

Tufts University

Are You a Good Fit for This Trial?

This trial is for Black or African American women in Massachusetts who are pregnant and will deliver at one of the four participating hospitals. It includes community doulas, obstetric care providers, and hospital staff involved with these patients. Excluded are pregnancies ending before 20 weeks or due to ectopic pregnancy not on labor units.

Inclusion Criteria

Pre- and post- surveys for Maternal Safety Bundles Implementation: Birthing individuals who have delivered six weeks to one year prior to the interview at the five participating sites in Intervention 1

Obstetrical care providers including nurses, midwives, family practitioners, attending obstetricians and trainee obstetricians employed at the five participating hospital sites will be invited to participate in focus groups.

Live births among birthing individuals who identify as Black or African American and who are offered community doula-support at one of the participating four hospitals, either through a hospital-based program or a payer navigation program.

Exclusion Criteria

Staff who have contact with clients but do not identify in the provider types listed in the inclusion criteria

Staff who have contact with patients but do not identify in the provider types listed in the inclusion criteria

My pregnancy ended before 20 weeks not due to an ectopic pregnancy in the specified hospitals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention 1: Maternal Safety Bundles Implementation

Implementation of maternal safety bundles targeting obstetric hemorrhage, severe hypertension, and maternal health equity.

6 months

Monthly visits for data collection and implementation support

Intervention 2: Doula Services

Evaluation and standardization of doula services to improve care and address inequities.

6 months

Monthly visits for training and evaluation

Follow-up

Participants are monitored for safety and effectiveness after interventions, including postpartum outcomes.

6-12 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Doula Services
• Implementation of Maternal Safety Bundles

Trial Overview The study tests how implementing maternal safety bundles and providing doula services affect severe maternal morbidity (SMM) and mortality among Black women. It uses surveys, data analysis, and interviews with healthcare providers and doulas to develop targeted care recommendations.

How Is the Trial Designed?

Group I: Maternal Safety Bundles Implementation Experimental Treatment 1 Intervention

The first intervention targets obstetric hemorrhage, severe hypertension and maternal health equity by implementing three relevant AIM bundles: Obstetric Hemorrhage, Severe Hypertension in Pregnancy, and Reduction of Peripartum Racial/Ethnic Disparities. The Perinatal Neonatal Quality Improvement Network (PNQIN) will facilitate this collaborative QI project and support participating hospitals by providing guidance, education, and technical assistance to hospitals to support implementation of bundles using the QI process. Implementation strategies are based on the Institute for Healthcare Improvement (IHI) improvement model and the AIM program implementation toolkit and have previously been used by PNQIN to implement the Obstetric Care for Women with Opioid Use Disorder AIM bundle in 22 hospitals, including the five hospitals for this study.

Group II: Doula Services Experimental Treatment 1 Intervention

The second intervention that this study evaluates is doula services. Investigators are evaluating doula services that are offered by two doula organizations at three hospitals. Investigators will provide top-up training to these doulas in order to provide some standardization and quality assurance of the services delivered. The training is developed and delivered by an obstetrician (Meadows) and doula (Gebel) and will take place among providers (staff associated with three chosen hospitals), patient navigators, and two doula groups, Birth Sisters and Accompany Doula Care, on factors that comprise the risk profile and how to offer targeted doula services to women who fit the risk profile. All sites will use standardized data instruments to evaluate the number of factors in the risk profile being met as well as standardized language and recruitment materials for mothers.

Implementation of Maternal Safety Bundles is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Maternal Safety Bundles for:

• Reducing severe maternal morbidity and mortality
• Improving maternal outcomes
• Addressing racial disparities in maternal health

Approved in European Union as Maternal Safety Bundles for:

• Improving maternal health outcomes
• Reducing maternal mortality and morbidity

Approved in Canada as Maternal Safety Bundles for:

• Enhancing maternal care
• Reducing maternal health disparities

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

UMass Memorial Health

Collaborator

Trials

4

Recruited

970+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Baystate Medical Center

Collaborator

Trials

67

Recruited

44,500+

Beth Israel Medical Center

Collaborator

Trials

71

Recruited

8,500+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

UMASS Memorial Medical Center

Collaborator

Trials

4

Recruited

3,900+

Steward St. Elizabeth's Medical Center of Boston, Inc.

Collaborator

Trials

26

Recruited

5,800+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

The National Partnership for Maternal Safety was established to address and reduce maternal mortality and morbidity in the U.S. by focusing on three major preventable causes: obstetric hemorrhage, severe hypertension in pregnancy, and peripartum venous thromboembolism.

The initiative includes specific strategies for improvement, such as recognizing early warning signs, conducting internal case reviews for system improvements, and providing support tools for those affected by adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National Partnership for Maternal Safety. D'Alton, ME., Main, EK., Menard, MK., et al.[2021]

This study aims to assess the feasibility of collecting detailed data on severe maternal morbidity (SMM) from maternity units across Canada, which could help improve maternal health care by identifying specific causes and circumstances leading to SMM.

The research will involve a cross-sectional survey and follow-up interviews with maternity unit leaders to understand their data-sharing capabilities and perceptions of SMM, ultimately aiming to establish a national obstetric survey system for better monitoring and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of establishing a Canadian Obstetric Survey System (CanOSS) for severe maternal morbidity: a study protocol. D'Souza, R., Seymour, RJ., Knight, M., et al.[2022]

Hemorrhage is the leading cause of severe maternal morbidity and preventable mortality, making it crucial to implement a national maternity patient safety bundle to address this issue.

The safety bundle consists of four key domains—Readiness, Recognition and Prevention, Response, and Reporting and System Learning—designed to standardize critical clinical practices across maternity units, with flexibility for adaptation based on individual facility resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Obstetric Hemorrhage. Main, EK., Goffman, D., Scavone, BM., et al.[2022]

The National Partnership for Maternal Safety has created a safety bundle aimed at reducing the high rates of primary cesarean births, which have become a significant public health concern.

This safety bundle includes critical practices organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning, allowing for adaptation to individual facilities while promoting standardization within institutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Safe Reduction of Primary Cesarean Births-Supporting Intended Vaginal Births. Lagrew, DC., Low, LK., Brennan, R., et al.[2019]

Maternal mortality in the USA has increased significantly, from 10 to 17 deaths per 100,000 live births between the 1990s and 2012, highlighting a critical public health issue.

Preventable measures, such as improved communication among healthcare providers, national care bundles for managing complications like hemorrhage, and better access to contraception, are essential for reducing maternal deaths and improving overall obstetric safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next steps to reduce maternal morbidity and mortality in the USA. Kilpatrick, SJ.[2016]

The National Partnership for Maternal Safety has developed a safety bundle aimed at reducing the high rates of primary cesarean births, which have become a significant public health concern.

This safety bundle includes critical practices organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning, allowing for adaptation to individual facilities while promoting standardization within institutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Safe Reduction of Primary Cesarean Births- Supporting Intended Vaginal Births. Lagrew, DC., Low, LK., Brennan, R., et al.[2019]

The US has a higher pregnancy-related mortality rate compared to other developed countries, with significant racial disparities, highlighting the urgent need for improved maternal care practices.

Implementing care bundles and protocols for early identification of maternal warning signs, particularly for obstetric hemorrhage and severe hypertension, has been shown to reduce adverse outcomes and preventable maternal deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Obstetric Safety Through Best Practices. Eppes, CS., Han, SB., Haddock, AJ., et al.[2021]

In a study of 156 cases of severe maternal morbidity (SMM) at Yale-New Haven Hospital over 4 years, the SMM rate was found to be 0.49%, with the main causes being hemorrhage (44.9%) and nonintrauterine infection (14.1%).

Two-thirds of the SMM cases were identified as preventable, primarily due to factors related to healthcare professionals (79.4%) and systemic issues (58.8%), highlighting the need for targeted practice changes to improve maternal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe Maternal Morbidity Review and Preventability Assessment in a Large Academic Center. Grechukhina, O., Lipkind, HS., Lundsberg, LS., et al.[2023]

Maternal morbidity and mortality rates are increasing in the United States, prompting organizations to focus on improving patient safety in obstetric care.

The implementation of early warning systems and standardized patient care bundles is crucial for early intervention and preventing complications, with ongoing monitoring of outcomes through root cause analysis to enhance safety and care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying Patient Safety to Reduce Maternal Mortality. Baptiste, C., D'Alton, ME.[2019]

The National Partnership for Maternal Safety has developed a safety bundle aimed at reducing the high rates of primary cesarean births, which have become a significant public health concern.

This safety bundle includes four key domains—Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning—providing a structured approach for maternity units to implement evidence-based practices and improve maternal safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Safe Reduction of Primary Cesarean Births-Supporting Intended Vaginal Births. Lagrew, DC., Kane Low, L., Brennan, R., et al.[2019]

Citations

1. pcori.org pcori.org/research-results/2023/comparing-effectiveness-doula-care-reducing-severe-maternal-morbidity

Comparing the Effectiveness of Doula Care for Reducing ... This study compares the clinical effectiveness of doula care utilization on pregnancy care and health outcomes after childbirth.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10292163/

The Effect of Doulas on Maternal and Birth Outcomes The studies in this review indicated that doula guidance in perinatal care was associated with positive delivery outcomes including reduced cesarean sections.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257331/

Doula care across the maternity care continuum and impact ... Women who received doula care during labor and birth, but not necessarily during pregnancy, showed a 64.7% reduction in odds of PPA/PPD (OR: 0.353 95% CI: 0.16– ...

4. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/dfcd768f1caf6fabf3d281f762e8d068/ASPE-Doula-Issue-Brief-12-13-22.pdf

Doula Care and Maternal Health: An Evidence Review Doula support during pregnancy, birth, and during the postpartum period has been shown to be an effective best practice that can enhance the ...

5. ajph.aphapublications.org ajph.aphapublications.org/doi/full/10.2105/AJPH.2024.307805

Role of Doulas in Improving Maternal Health and Health ... Results indicate females with doulas had a 47% lower risk of cesarean delivery and a 29% lower risk of preterm birth, and were 46% more likely ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1049386724000215

United States Doula Programs and Their Outcomes Some studies have found associations between doula care and improved clinical outcomes for birthing people and infants, the evidence is limited.

7. macpac.gov macpac.gov/wp-content/uploads/2023/11/Doulas-in-Medicaid-Case-Study-Findings.pdf

Doulas in Medicaid: Case Study Findings Studies have shown that doula support during pregnancy, birth, and postpartum is linked to improved maternal and infant health outcomes. For ...