R01HL166836

The Heart Outcomes for Pregnancy Expectations Study - Project Abstract/Summary

The US not only has the highest rate of maternal mortality in the developed world but is the only country in which this rate is rising.

It is also notorious for marked racial disparities, with Black maternal deaths being 3-4 times greater than that of White pregnant people.

While affecting only 4% of pregnancies, cardiovascular disease (CVD) accounts for up to 30% of maternal deaths and yet there is no evidence about how best to stratify risk or deliver care in this population.

While Cardio-Obstetrics (COB) clinics have emerged, with encouragement and support from both the AHA and ACOG, these have been implemented with very heterogeneous structures.

In collaboration with a large network of COB clinics, we have identified 5 structural components of care that have been variably deployed and for which further evidence is needed to define whether any of these components independently improves outcomes.

Along with 33 partner sites, we propose the first-ever, US-based, prospective evaluation of 1000 (40% minorities) consecutive pregnant people with CVD to identify clinical, patient-reported (including perceived discrimination) and structural characteristics of care associated with adverse pregnancy outcomes (APO), maternal adverse cardiac outcomes (MACE), neonatal adverse clinical events (NACE) and quality of life (QOL).

Our study will address both the exceedingly high prevalence of adverse outcomes and racial disparities in pregnancy by:

1) Identifying patient characteristics, at the time of prenatal care initiation and throughout pregnancy, associated with APOs, NACE and MACE with a special focus on racial disparities; and

2) By adjusting for these factors, define the independent association of alternative structures of care so that future COB clinics can be developed to optimize outcomes.

We will prospectively collect detailed patient-level variables, and the first-ever serial assessment of quality of life data, from initial COB presentation and throughout pregnancy, delivery and 1 year postpartum.

This will be the first national, multisite, prospective study of pregnant people with CV disease ever conducted in the US and is critically important to address our country's marked disparities and rising maternal morbidity and mortality.

This work will be the foundation for future RCTs.

To accelerate the translation of our findings to clinical practice, we have actively engaged dissemination partners from the design phase of the program to join us in the analysis and interpretation of our findings so as to accelerate their efforts to improve maternal care.

The Curators Of The University Of Missouri

TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Kansas City, Missouri 641113220 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)

Amendment Since initial award the total obligations have increased 88% from $2,428,701 to $4,577,952.