The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study

C
Caroline Rouse, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
Female
Phase N/A
10 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - This study is enrolling participants from specified community and academically-based medical centers with self-defined cardio-obstetrics clinics who are identified to have have structural, ischemic, or clinically significant arrhythmic CV disease diagnosed prior to or during pregnancy, but prior to delivery.

Detailed description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pregnancy, Pregnant, Cardiovascular disease, Heart disease, Congenital heart disease, Aortopathy, Arrhythmia, Cardiomyopathy, Heart failure, Coronary disease, Endocarditis, Pericarditis, Pericardial effusion, Pulmonary hypertension
  • Age: 18 years - 100 years
  • Gender: Female

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

Updated on 09 Dec 2025. Study ID: OBGYN-UMKC-HOPE, 26216
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only