Status:
RECRUITING
The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study
Lead Sponsor:
University of Missouri, Kansas City
Collaborating Sponsors:
Albert Einstein College of Medicine
Baylor College of Medicine
Conditions:
Pregnancy Complications, Cardiovascular
Eligibility:
FEMALE
18+ years
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 c...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06517628
Start Date
January 14 2025
End Date
June 30 2028
Last Update
January 20 2025
Active Locations (1)
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1
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111