The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study

NCT06517628 | Recruiting

• 1 other identifier: 0073599
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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 cardio-obstetrics care to optimize outcomes.

Conditions

Pregnancy Complications, Cardiovascular

Keywords

Pregnancy, cardio-obstetrics; Structures of Care; Quality of Care; Disparities; Heart disease in pregnancy; Pregnancy complications; Adverse pregnancy outcomes; Major adverse cardiac events; Neonatal adverse events; Quality of life

Outcome Measures

Primary Outcomes (1)

• Rate of Adverse pregnancy outcomes

  HELLP, preeclampsia, gestational hypertension, eclampsia, superimposed preeclampsia on chronic hypertension (SIPE), premature preterm rupture of membranes (PPROM), preterm delivery, thrombotic complications, hemorrhage, maternal mortality, placental abruption, Admission ICU delivery

  up to 6 weeks postpartum

Secondary Outcomes (2)

• Rate of Maternal Adverse Cardiac Events (MACE)

  Up to 1 year postpartum

• Rate of Neonatal adverse clinical events (NACE)

  Through maternal hospital discharge

Other Outcomes (8)

• Changes in Generic Quality of Life as Assessed by the Short Form-36

  Through 1 year post partum

• Changes in Depressive Symptoms, as Assessed by the Edinburgh Postpartum Depression Scale

  Through 1 year post partum

• Experiences with pregnancy care and delivery will be assessed with the Childbirth Experience Survey

  Third trimester and 6 weeks after delivery

Study Arms (1)

Pregnant people with cardiovascular disease

Any pregnant patient with acquired or congenital cardiovascular disease upon presentation to a cardio-obstetrics clinic.

Other: Purely observational study on the care and outcomes of participants with cardiovascular disease in pregnancy.

Interventions

Purely observational study on the care and outcomes of participants with cardiovascular disease in pregnancy. OTHER

The primary exposure variable is the organization of cardio-obstetrics care which will be defined by annual site surveys and its association with outcomes will be defined by hierarchical models adjusting for patient characteristics.

Pregnant people with cardiovascular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant people with cardiovascular disease

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• Albert Einstein College of Medicine: collaborator
• Baylor College of Medicine: collaborator
• Beth Israel Deaconess Medical Center, Inc.: collaborator
• The Children's Hospital Corporation: collaborator
• The Brigham and Women's Hospital, Inc.: collaborator
• The Trustees of Columbia University in the City of New York: collaborator
• Henry Ford Hospital: collaborator
• The Johns Hopkins University: collaborator
• The Miriam Hospital/Lifespan: collaborator
• The General Hospital Corporation d/b/a Massachusetts General Hospital: collaborator
• Northwell Health: collaborator
• Northwestern University: collaborator
• Oregon Health and Science University: collaborator
• Saint Luke's Health System Inc.: collaborator
• Board of Trustees of the Leland Stanford Junior University: collaborator
• The Research Foundation for the State University of New York: collaborator
• The Regents of the University of California, Irvine: collaborator
• The Regents of the University of California, Los Angeles: collaborator
• University of North Carolina, Chapel Hill: collaborator
• The Board of Trustees of the University of Illinois: collaborator
• Trustees of Indiana University: collaborator
• University of Kansas Medical Center: collaborator
• University of Massachusetts Chan Medical School: collaborator
• Regents of the University of Michigan: collaborator
• University of Mississippi Medical Center: collaborator
• The Curators of the University of Missouri: collaborator
• The Trustees of the University of Pennsylvania: collaborator
• University of Pittsburgh: collaborator
• The University of South Florida Board of Trustees for University of South Florida: collaborator
• University of Washington: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Weil Medical Colleqe of Cornell University: collaborator
• Women and Infants Hospital of Rhode Island: collaborator
• Tennessee Maternal Fetal Medicine PLC: collaborator

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications, Cardiovascular; Pregnancy Complications; Cardiovascular Diseases

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• John Spertus, MD, MPH

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen L Florio, DO, MPH

CONTACT

631-579-1030; klwa42@umsystem.edu

Anna Grodzinsky, MD, MS

CONTACT

816-932-2000; agrodzinsky@saint-lukes.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 24, 2024
• Study Start: January 14, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The HOPE team commits to providing the data as soon as possible, but no sooner than 1 year after the completion of follow-up of the last patient. The Steering/Publications Committee will annually review any additions to the data set, including the creation of composite variables, to explore whether updates to the deposited data are needed and, if so, these will be made within 3 months of their creation/addition.
• Access Criteria: unrestricted

Locations

US (1)