Clinical trial NCT06517628: The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study
Official title: The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Complications, Cardiovascular
Keywords: Pregnancy, cardio-obstetrics
Structures of Care
Quality of Care
Disparities
Heart disease in pregnancy
Pregnancy complications
Adverse pregnancy outcomes
Major adverse cardiac events
Neonatal adverse events
Quality of life
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
name: Baylor College of Medicine
name: Beth Israel Deaconess Medical Center, Inc.
name: The Children's Hospital Corporation
name: The Brigham and Women's Hospital, Inc.
name: The Trustees of Columbia University in the City of New York
name: Henry Ford Hospital
name: The Johns Hopkins University
name: The Miriam Hospital/Lifespan
name: The General Hospital Corporation d/b/a Massachusetts General Hospital
name: Northwell Health
name: Northwestern University
name: Oregon Health and Science University
name: Saint Luke's Health System Inc.
name: Board of Trustees of the Leland Stanford Junior University
name: The Research Foundation for the State University of New York
name: The Regents of the University of California, Irvine
name: The Regents of the University of California, Los Angeles
name: University of North Carolina, Chapel Hill
name: The Board of Trustees of the University of Illinois
name: Trustees of Indiana University
name: University of Kansas Medical Center
name: University of Massachusetts Chan Medical School
name: Regents of the University of Michigan
name: University of Mississippi Medical Center
name: The Curators of the University of Missouri
name: The Trustees of the University of Pennsylvania
name: University of Pittsburgh
name: The University of South Florida Board of Trustees for University of South Florida
name: University of Washington
name: UT Southwestern Medical Center
name: Weil Medical Colleqe of Cornell University
name: Women and Infants Hospital of Rhode Island
name: Tennessee Maternal Fetal Medicine PLC
First posted: 2024-07-24
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant people with cardiovascular disease

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.

Eligibility criteria: Inclusion:

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

Primary outcomes:
measure: Rate of Adverse pregnancy outcomes
timeFrame: up to 6 weeks postpartum
Secondary outcomes:
measure: Rate of Maternal Adverse Cardiac Events (MACE)
timeFrame: Up to 1 year postpartum
measure: Rate of Neonatal adverse clinical events (NACE)
timeFrame: Through maternal hospital discharge
Other outcomes:
measure: Changes in Generic Quality of Life as Assessed by the Short Form-36
timeFrame: Through 1 year post partum
measure: Changes in Depressive Symptoms, as Assessed by the Edinburgh Postpartum Depression Scale
timeFrame: Through 1 year post partum
measure: Experiences with pregnancy care and delivery will be assessed with the Childbirth Experience Survey
timeFrame: Third trimester and 6 weeks after delivery
measure: Perceived Discrimination will be assessed using the Experience of Depression Scale
timeFrame: Enrollment and 6 and 12 months after delivery
measure: Self-perceived Health Status will be assessed using a version of the Kansas City Cardiomyopathy Questionnaire Modified for Pregnancy
timeFrame: Enrollment, 3rd Trimester, and 6 weeks, 6 months and 12 months after delivery
measure: Coronary-specific Health Status over Time among Participants with a History of Coronary Disease
timeFrame: Enrollment, 3rd Trimester, and 6 weeks and 12 months after delivery
measure: Atrial Fibrillation-specific Health Status over Time among Participants with a History of Atrial Fibrillation
timeFrame: Enrollment, 3rd Trimester, and 6 weeks and 12 months after delivery
measure: Disease-specific Health Status over Time among Participants with a History of Congenital Heart Disease
timeFrame: Enrollment, 3rd Trimester, and 6 weeks and 12 months after delivery
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: John Spertus, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: