An observational study in Pregnancy Complications, Cardiovascular, sponsored by University of Missouri, Kansas City. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by University of Missouri, Kansas City · Observational
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.
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:
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.
411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 400 across 198 observational studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →University of Missouri, Kansas City is the lead sponsor of 48 studies on the registry; 9 are open to participants now.
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Pregnant people with cardiovascular disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must have one or more condition(s) within the 6 following categories - Repaired or Unrepaired
Exclusion Criteria
Any pregnant patient with acquired or congenital cardiovascular disease upon presentation to a cardio-obstetrics clinic.
Other: 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.
Rate of Adverse pregnancy outcomes
HELLP, preeclampsia, gestational hypertension, eclampsia, superimposed preeclampsia on chronic hypertension (SIPE), premature preterm rupture of membranes (PPROM), preterm delivery, thrombotic complications, hemorrhage, maternal mortality, placental abruption, Admission ICU delivery
Time frame: up to 6 weeks postpartum
Rate of Maternal Adverse Cardiac Events (MACE)
A composite outcome including any of the following: cardiovascular death, non-fatal stroke, myocardial infarction, hospitalization for acute coronary syndromes, urgent revascularization procedures, decompensated heart failure, aortic dissection, clinically significant arrhythmia requiring treatment (eg. atrial fibrillation/flutter, SVT, ventricular tachycardia, etc), cardiac transplant
Time frame: Up to 1 year postpartum
Rate of Neonatal adverse clinical events (NACE)
A composite outcome including any of the following: APGARS \< 8 at 5 minutes, birthweight of \< 2500 grams, NICU admission, supplemental oxygen use, neonatal death, fetal death, spontaneous abortion/miscarriage, intrauterine fetal growth restriction
Time frame: Through maternal hospital discharge
Changes in Generic Quality of Life as Assessed by the Short Form-36
All patients will complete the Short Form-36 on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care.
Time frame: Through 1 year post partum
Changes in Depressive Symptoms, as Assessed by the Edinburgh Postpartum Depression Scale
This questionnaire will be completed on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care.
Time frame: Through 1 year post partum
Experiences with pregnancy care and delivery will be assessed with the Childbirth Experience Survey
This questionnaire will be completed during the 3rd trimester and 6 weeks after delivery and will be compared by patient characteristics and structures of care.
Time frame: Third trimester and 6 weeks after delivery
Perceived Discrimination will be assessed using the Experience of Depression Scale
This questionnaire will be completed on enrollment and at 6 and 12 months after delivery so that cross-sectional and changes over time through 1 year after delivery can be compared by patient characteristics and structures of care.
Time frame: Enrollment and 6 and 12 months after delivery
Self-perceived Health Status will be assessed using a version of the Kansas City Cardiomyopathy Questionnaire Modified for Pregnancy
This questionnaire will be completed on enrollment and changes over time through 1 year after delivery will be compared by patient characteristics and structures of care.
Time frame: Enrollment, 3rd Trimester, and 6 weeks, 6 months and 12 months after delivery
Coronary-specific Health Status over Time among Participants with a History of Coronary Disease
This questionnaire will be completed by participants with a history of coronary artery disease (including SCAD) on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care.
Time frame: Enrollment, 3rd Trimester, and 6 weeks and 12 months after delivery
Atrial Fibrillation-specific Health Status over Time among Participants with a History of Atrial Fibrillation
This questionnaire will be completed by participants with a history of atrial fibrillation on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care.
Time frame: Enrollment, 3rd Trimester, and 6 weeks and 12 months after delivery
Disease-specific Health Status over Time among Participants with a History of Congenital Heart Disease
This questionnaire will be completed by participants with a history of congenital heart disease on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care.
Time frame: Enrollment, 3rd Trimester, and 6 weeks and 12 months after delivery
Plan to share: Yes — Data will be deposited into BioLincc (https://biolincc.nhlbi.nih.gov/). These data will be provided in a completely de-identified format with random shifting of dates that are internally consistent with the participant's actual experiences.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The HOPE team commits to providing the data as soon as possible, but no sooner than 1 year after the completion of follow-up of the last patient. The Steering/Publications Committee will annually review any additions to the data set, including the creation of composite variables, to explore whether updates to the deposited data are needed and, if so, these will be made within 3 months of their creation/addition.
Access criteria: unrestricted
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University of Missouri, Kansas City