The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study
NCT Number: NCT06517628
Acronym: HOPE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pregnancy Complications, Cardiovascular
Interventions: OTHER: Purely observational study on the care and outcomes of participants with cardiovascular disease in pregnancy.
Sponsor: University of Missouri, Kansas City
Collaborators: Albert Einstein College of Medicine|Baylor College of Medicine|Beth Israel Deaconess Medical Center, Inc.|The Children's Hospital Corporation|The Brigham and Women's Hospital, Inc.|The Trustees of Columbia University in the City of New York|Henry Ford Hospital|The Johns Hopkins University|The Miriam Hospital/Lifespan|The General Hospital Corporation d/b/a Massachusetts General Hospital|The Feinstein Institutes for Medical Research|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 Chan Medical School|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|The University of South Florida Board of Trustees for University of South Florida|University of Washington|UT Southwestern Medical Center|Weil Medical Colleqe of Cornell University|Women and Infants Hospital of Rhode Island|Tennessee Maternal Fetal Medicine PLC
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2028-06-30

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.

Primary Outcome Measures: 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 Outcome Measures: Rate of Maternal Adverse Cardiac Events (MACE), A composite outcome including any of the following: cardiovascular death, non-fatal stroke, myocardial infarction, hospitalization for acute coronary syndromes, urgent revascularization procedures, decompensated heart failure, aortic dissection, clinically significant arrhythmia requiring treatment (eg. atrial fibrillation/flutter, SVT, ventricular tachycardia, etc), cardiac transplant, Up to 1 year postpartum|Rate of Neonatal adverse clinical events (NACE), A composite outcome including any of the following: APGARS \< 8 at 5 minutes, birthweight of \< 2500 grams, NICU admission, supplemental oxygen use, neonatal death, fetal death, spontaneous abortion/miscarriage, intrauterine fetal growth restriction, Through maternal hospital discharge
Other Outcome Measures: Changes in Generic Quality of Life as Assessed by the Short Form-36, All patients will complete the Short Form-36 on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care., Through 1 year post partum|Changes in Depressive Symptoms, as Assessed by the Edinburgh Postpartum Depression Scale, This questionnaire will be completed on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care., Through 1 year post partum|Experiences with pregnancy care and delivery will be assessed with the Childbirth Experience Survey, This questionnaire will be completed during the 3rd trimester and 6 weeks after delivery and will be compared by patient characteristics and structures of care., Third trimester and 6 weeks after delivery|Perceived Discrimination will be assessed using the Experience of Depression Scale, This questionnaire will be completed on enrollment and at 6 and 12 months after delivery so that cross-sectional and changes over time through 1 year after delivery can be compared by patient characteristics and structures of care., Enrollment and 6 and 12 months after delivery|Self-perceived Health Status will be assessed using a version of the Kansas City Cardiomyopathy Questionnaire Modified for Pregnancy, This questionnaire will be completed on enrollment and changes over time through 1 year after delivery will be compared by patient characteristics and structures of care., Enrollment, 3rd Trimester, and 6 weeks, 6 months and 12 months after delivery|Coronary-specific Health Status over Time among Participants with a History of Coronary Disease, This questionnaire will be completed by participants with a history of coronary artery disease (including SCAD) on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care., Enrollment, 3rd Trimester, and 6 weeks and 12 months after delivery|Atrial Fibrillation-specific Health Status over Time among Participants with a History of Atrial Fibrillation, This questionnaire will be completed by participants with a history of atrial fibrillation on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care., Enrollment, 3rd Trimester, and 6 weeks and 12 months after delivery|Disease-specific Health Status over Time among Participants with a History of Congenital Heart Disease, This questionnaire will be completed by participants with a history of congenital heart disease on enrollment and changes over time through 1 year after delivery and will be compared by patient characteristics and structures of care., Enrollment, 3rd Trimester, and 6 weeks and 12 months after delivery