The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study

NCT ID: NCT06517628

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2028-06-30

Brief Summary

This is a prospective, observational study which is evaluating the obstetrical, neonatal, and cardiovascular outcomes of 1000 pregnant people with known heart disease to define how best to structure cardio-obstetrics care to optimize outcomes.

Detailed Description

The US is the only industrialized nation to experience a rise in maternal mortality over the last decade. Despite the Healthy People 2030 agenda target of reducing maternal mortality by 10%, rates in the United States are predicted to increase. Furthermore, maternal mortality disproportionately impacts Black, Hispanic, American Indian/Alaskan Native (AIAN), and Asian/Pacific Islander birthing people, who die at a rate that far greater than their White counterparts. Black birthing people are twice as likely to experience severe maternal morbidity (SMM) and 3-4X more likely to die, even after adjusting for demographic and hospital factors. Unfortunately, this gap is widening, with a 20% increase in death for Blacks as compared with a 5% rise in Whites over the last decade. Understanding contributors to adverse outcomes for marginalized birthing populations cannot solely be determined from retrospective chart adjudication and requires prospective evaluation to better understand patient and treatment factors contributing to maternal morbidity and mortality.

Despite affecting only 2-4% of pregnancies, cardiovascular disease (CVD) accounts for >30% of maternal deaths, making it a leading cause of maternal mortality for all birthing people and the number one cause in the Black population. Pregnant people with acquired and congenital heart disease experience the majority of CV-related morbidity and mortality, of which over three quarters have been deemed preventable. The prevalence of CVD is expected to grow as risk factors for CV-related death (obesity, advanced maternal age, hypertensive disorders, and preexisting heart disease) are rising dramatically in pregnant people, which disproportionately burdens marginalized populations. Provider-based factors are a leading cause of preventable morbidity, yet the lack of evidence-based guidelines, means of risk-stratifying pregnant people with CVD, or insight into how best to structure care limits the ability to improve maternal outcomes.

Mortality is not the only important outcome for pregnant people with CVD. For every maternal death, it is estimated that 100 people - 50,000 per year - will suffer severe maternal morbidity (SMM) during delivery, with significant costs to both their families and the economy. Adverse pregnancy outcomes (APOs) and neonatal adverse clinical events (NACEs), including pre-eclampsia, preterm delivery, fetal growth restriction, stillbirth and maternal hemorrhage, are all significantly more common in those with heart disease. Pregnant people who survive these events are more likely to suffer post-traumatic stress and depression, which can adversely impact mother-child bonding and long-term health. Importantly, there are no studies in this population evaluating quality of life, which cannot be measured using retrospective data.

To address the critical need for reversing the US trend in maternal morbidity and mortality, the Heart Outcomes in Pregnancy Expectations (HOPE) study will focus on the highest risk population, pregnant people with CVD. It will provide deeper insights into maternal risk factors, their association with care, and the influence of alternative structures of cardio-obstetric care with APO, MACE, and NACE outcomes. It is a multi-site, multidisciplinary prospective study at >30 cardio-obstetrics clinics throughout the US with a key secondary goal of better understanding racial disparities in care and outcomes. Not only will traditional APOs, MACE, and NACE events from presentation to 1-year after delivery be collected, generic and disease-specific quality of life will be measured as a way to evaluate their independent impact on outcomes.

Preliminary insights through our pilot program highlight the importance of better structures of care as a means of improving outcomes, which has previously been established in other clinical settings, but not in cardio-obstetrics care. The investigators have identified 6 key structures of care that have been variably adopted through the US and for which additional data to define their independent association with outcomes is needed.

These include:

1. multidisciplinary (OB/maternal-fetal medicine [MFM], cardiology, anesthesia, critical care, etc.) care teams;

2. a COB care coordinator;

3. coordinated inter-disciplinary patient evaluation;

4. team debriefing

5. the ability to perform high-risk deliveries in the ICU and

6. formalized warm hand offs to primary or sub-specialty care after delivery.

After adjusting for extensive patient factors associated with adverse outcomes, the independent association of these structures of care with outcomes will be estimated as a foundation for testing and disseminating those that are most effective.

Conditions

Pregnancy Complications, Cardiovascular

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant people with cardiovascular disease

Any pregnant patient with acquired or congenital cardiovascular disease upon presentation to a cardio-obstetrics clinic.

Purely observational study on the care and outcomes of participants with cardiovascular disease in pregnancy.

Intervention Type: OTHER

The primary exposure variable is the organization of cardio-obstetrics care which will be defined by annual site surveys and its association with outcomes will be defined by hierarchical models adjusting for patient characteristics.

Interventions

Purely observational study on the care and outcomes of participants with cardiovascular disease in pregnancy.

The primary exposure variable is the organization of cardio-obstetrics care which will be defined by annual site surveys and its association with outcomes will be defined by hierarchical models adjusting for patient characteristics.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Must have one or more condition(s) within the 6 following categories - Repaired or Unrepaired

• Congenital or structural heart disease
• Aortopathies
• Arrhythmias
• Cardiomyopathies and Heart Failure
• Coronary disease
• Other (Current endocarditis or history of endocarditis, Pericarditis, Pericardial effusion - Moderate or Large, Pericardial constriction, Pulmonary hypertension (all types) defined as mean pulmonary artery systolic pressure of >20 mmHg by right heart catheterization or pulmonary hypertension estimated in the severe range by echo)

Exclusion Criteria

• Unable to participate in telephone follow-up
• Too hard of hearing to do follow-up by telephone or deaf
• Incarcerated prisoner
• History of dementia.
• Subjects without a way for contact by telephone for follow-up
• Refused participation in the study
• Unable to consent for self
• Traumatic Aortic Disease
• Peripartum cardiomyopathy diagnosed in current pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center, Inc.

UNKNOWN

Sponsor Role: collaborator

The Children's Hospital Corporation

UNKNOWN

Sponsor Role: collaborator

The Brigham and Women's Hospital, Inc.

UNKNOWN

Sponsor Role: collaborator

The Trustees of Columbia University in the City of New York

UNKNOWN

Sponsor Role: collaborator

Henry Ford Hospital

OTHER

Sponsor Role: collaborator

The Johns Hopkins University

UNKNOWN

Sponsor Role: collaborator

The Miriam Hospital/Lifespan

UNKNOWN

Sponsor Role: collaborator

The General Hospital Corporation d/b/a Massachusetts General Hospital

UNKNOWN

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Saint Luke's Health System Inc.

UNKNOWN

Sponsor Role: collaborator

Board of Trustees of the Leland Stanford Junior University

UNKNOWN

Sponsor Role: collaborator

The Research Foundation for the State University of New York

UNKNOWN

Sponsor Role: collaborator

The Regents of the University of California, Irvine

UNKNOWN

Sponsor Role: collaborator

The Regents of the University of California, Los Angeles

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

The Board of Trustees of the University of Illinois

UNKNOWN

Sponsor Role: collaborator

Trustees of Indiana University

UNKNOWN

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

University of Massachusetts Chan Medical School

UNKNOWN

Sponsor Role: collaborator

Regents of the University of Michigan

UNKNOWN

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

The Curators of the University of Missouri

UNKNOWN

Sponsor Role: collaborator

The Trustees of the University of Pennsylvania

UNKNOWN

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

The University of South Florida Board of Trustees for University of South Florida

UNKNOWN

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

UT Southwestern Medical Center

UNKNOWN

Sponsor Role: collaborator

Weil Medical Colleqe of Cornell University

UNKNOWN

Sponsor Role: collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: collaborator

Tennessee Maternal Fetal Medicine PLC

UNKNOWN

Sponsor Role: collaborator

University of Missouri, Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Spertus, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Missouri, Kansas City

Locations

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen L Florio, DO, MPH

Role: CONTACT

klwa42@umsystem.edu

631-579-1030

Anna Grodzinsky, MD, MS

Role: CONTACT

agrodzinsky@saint-lukes.org

816-932-2000

Facility Contacts

Rosann Gans, RN, BSN

Role: primary

rgans@saint-lukes.org

816-932-6122

Nancy Stone, MEd

Role: backup

nanstone@saint-lukes.org

8169325367

Other Identifiers

0073599

Identifier Type: -

Identifier Source: org_study_id