Actively Recruiting

Age: 18Years +
FEMALE
ID06517628

The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study Observing Pregnancy and Heart Disease Outcomes

Led by University of Missouri, Kansas City · Updated on 2025-01-20

1000

Participants Needed

1

Research Sites

180 weeks

Total Duration

On this page

Sponsors

U

University of Missouri, Kansas City

Lead Sponsor

A

Albert Einstein College of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to better understand the obstetrical, neonatal, and heart-related outcomes of 1000 pregnant individuals who have known heart disease. Cardiovascular disease is a leading cause of maternal death in the United States, especially affecting Black, Hispanic, American Indian/Alaskan Native, and Asian/Pacific Islander populations more severely than White populations. The study focuses on evaluating how different methods of cardio-obstetrics care can improve outcomes and reduce health disparities in these high-risk groups. The study is purely observational and involves multiple cardio-obstetrics clinics across the US. It examines how the organization of cardio-obstetrics care at each site relates to patient outcomes. Key care structures being evaluated include multidisciplinary care teams, care coordinators, coordinated evaluations, team debriefings, ICU deliveries, and formal hand-offs after delivery. Data will be collected on pregnancy complications, cardiovascular events, and quality of life measures from pregnancy through one year postpartum. Participants will be followed from pregnancy through delivery and up to one year after birth. Researchers will collect information through site surveys, patient evaluations, and telephone follow-ups. Outcomes such as adverse pregnancy events and cardiovascular complications will be monitored, along with quality of life assessments. Safety and long-term health will be evaluated to identify care practices that best support pregnant individuals with heart disease and their babies.

CONDITIONS

Official Title

The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Must have one or more of the following conditions, either repaired or unrepaired: congenital or structural heart disease, aortopathies, arrhythmias, cardiomyopathies and heart failure, coronary disease, or other specified heart-related conditions including endocarditis, pericarditis, pericardial effusion, pericardial constriction, or pulmonary hypertension
Not Eligible

You will not qualify if you...

  • Unable to participate in telephone follow-up
  • Severe hearing impairment or deafness preventing telephone follow-up
  • Currently an incarcerated prisoner
  • History of dementia
  • No telephone contact method available for follow-up
  • Refusal to participate in the study
  • Unable to provide informed consent
  • Traumatic aortic disease
  • Diagnosed with peripartum cardiomyopathy in the current pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States, 64111

Actively Recruiting

Loading map...

Research Team

K

Karen L Florio, DO, MPH

A

Anna Grodzinsky, MD, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here