The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Missouri, Kansas City
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Congenital or structural heart disease
Aortopathies
Arrhythmias
Cardiomyopathies and Heart Failure
Disqualifiers
Unable to participate in telephone follow-up
Too hard of hearing to do follow-up by telephone or deaf
Incarcerated prisoner
History of dementia.
Trial population
Pregnant people with cardiovascular disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Purely observational study on the care and outcomes of participants with cardiovascular disease in pregnancy.
Other interventionThe 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.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Pregnant people with cardiovascular disease1 intervention
Trial outcomes
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
Time frame
up to 6 weeks postpartumSecondary outcomes
1
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
Time frame
Up to 1 year postpartum2
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
Time frame
Through maternal hospital dischargeOther outcomes
1
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.
Time frame
Through 1 year post partum2
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.
Time frame
Through 1 year post partum3
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.
Time frame
Third trimester and 6 weeks after delivery4
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.
Time frame
Enrollment and 6 and 12 months after deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Missouri, Kansas City
Lead sponsor
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
Columbia University
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, Worcester
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
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
Source ClinicalTrials.gov