Evaluating heart health outcomes in pregnant individuals with heart disease
The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study
This study looks at the health outcomes for pregnant people with heart disease to see how to improve care for them and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Missouri, Kansas City Academic / other |
| Locations | 1 site (Kansas City, Missouri) |
| Trial ID | NCT06517628 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the obstetrical, neonatal, and cardiovascular outcomes of 1000 pregnant individuals with known heart disease. It seeks to identify optimal structures for cardio-obstetrics care to improve maternal and neonatal health outcomes. The study addresses the rising maternal mortality rates in the U.S., particularly among marginalized populations, by focusing on the significant impact of cardiovascular disease during pregnancy. By collecting prospective data, the study aims to uncover factors contributing to maternal morbidity and mortality, especially in communities disproportionately affected by these issues.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals with one or more specific cardiovascular conditions, such as congenital heart disease, arrhythmias, or cardiomyopathies.
Not a fit: Patients who are unable to participate in follow-up or have conditions like traumatic aortic disease or peripartum cardiomyopathy diagnosed in the current pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved care strategies that significantly reduce maternal and neonatal morbidity and mortality in pregnant individuals with heart disease.
How similar studies have performed: Other studies have highlighted the importance of addressing cardiovascular health in pregnancy, but this specific approach focusing on marginalized populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Missouri
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: John Spertus, MD, MPH — University of Missouri, Kansas City
- Study coordinator: Karen L Florio, DO, MPH
- Email: klwa42@umsystem.edu
- Phone: 631-579-1030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.