NCT06517628 · University of Missouri, Kansas City
The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study
(HOPE)
What this study is about
This is a forward-looking, 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.
View original scientific description
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.
Interventions
OTHER
Purely observational study on the care and outcomes of participants with cardiovascular disease in pregnancy.
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.
Primary outcome measures
Rate of Adverse pregnancy outcomes
Time frame: up to 6 weeks postpartum
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Kansas City, Missouri
Collaborators
Albert Einstein College of Medicine, Baylor College of Medicine, Beth Israel Deaconess Medical Center, The Children's Hospital Corporation, The Brigham and Women's Hospital, Inc., Columbia University, Henry Ford Hospital, The Johns Hopkins University, The Miriam Hospital/Lifespan, The General Hospital Corporation d/b/a Massachusetts General Hospital, Northwell Health, Northwestern University, Oregon Health and Science University, Saint Luke's Health System Inc., Board of Trustees of the Leland Stanford Junior University, The Research Foundation for the State University of New York, The Regents of the University of California, Irvine, The Regents of the University of California, Los Angeles, University of North Carolina, Chapel Hill, The Board of Trustees of the University of Illinois, Trustees of Indiana University, University of Kansas Medical Center, University of Massachusetts, Worcester, Regents of the University of Michigan, University of Mississippi Medical Center, The Curators of the University of Missouri, The Trustees of the University of Pennsylvania, University of Pittsburgh, University of South Florida, University of Washington, University of Texas Southwestern Medical Center, Weil Medical Colleqe of Cornell University, Women and Infants Hospital of Rhode Island, Tennessee Maternal Fetal Medicine PLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2025 · Source of record for eligibility and locations