- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04828070
The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry
The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry Pilot
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The maternal mortality rate in the United States continues to climb, with cardiovascular disease as the leading cause for death in and around pregnancy. The racial disparities in the United States are also concerning as African American women have a 4-fold higher risk as compared to their Caucasian, Asian, or Hispanic counterparts. A Review To Action report, a collaboration of nine states' maternal mortality review committees, published in July 2018 determined that 63% of these deaths were preventable. Most deaths were related to clinical, facility and system factors, including missed or delayed diagnosis, inefficient response to obstetrical emergencies and poor communication and coordination between team members. Understanding these trends on a national level is imperative if any notable change is to be made. This requires filling the knowledge gaps that currently exist, which can be accomplished by a national registry.
Marked improvements in treating congenital heart disease have led to more women with repaired congenital cardiac malformations reaching reproductive age and desiring fertility. Beyond the growth in the prevalence of congenital heart disease, acquired cardiac disease-peripartum cardiomyopathy, ischemic heart disease, aortic dissection- are increasing and are associated with the highest risk of maternal mortality. This is particularly notable in the United States as compared to other countries where the rates of obesity and metabolic disorders approach one-third of the adult population. Adding to the complexity of the American demographics is the growing birthrate in women over 35 years of age. These trends mandate a reconceptualization of maternity care to recognize the changing demographics of pregnancy in the United States and how the growing prevalence of cardiac disease complicates care.
Other countries, particularly in Europe, have begun to investigate these issues, and as a result, their maternal mortality rates are far better than the US. Part of the European decline can be attributed to their robust prospective databases that assess pregnancy throughout the antepartum and postpartum time frame. It is becoming the dominant source of data in the medical literature describing the outcomes of patients with cardiac disease in pregnancy, yet there is no such equivalent in the United States. Investigators have yet to define the risks of pregnancy on both congenital and acquired disease states, a critical knowledge gap that could be answered with a prospective, observational registry of women with heart disease. The investigators propose to lead a prospective US registry of pregnant women with cardiac disease to address the substantial gaps in knowledge surrounding the baseline, clinical characteristics, and long-term maternal-fetal outcomes.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Anna Grodzinsky, MD
- Phone Number: 816-931-1883
- Email: agrodzinsky@saint-lukes.org
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Recruiting
- Saint Luke's Hospital of Kansas City
-
Contact:
- Karen Florio, DO
- Phone Number: 816-932-0270
- Email: kflorio@saint-lukes.org
-
Contact:
- April Smith
- Phone Number: 816-932-5019
- Email: aprlsmith1@saint-lukes.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 and older
- Pregnant at any point in gestation (with singleton or multiple gestation)
History of congenital and/or acquired heart disease defined as the following:
- valvular, congenital, ischemic heart disease or cardiomyopathy,
- clinically significant maternal arrhythmias in women,
- current or previous history of peripartum cardiomyopathy,
- supraventricular tachycardia,
- placement of either a pacemaker or electrical assist device,
- aortopathies (Marfan syndrome, Loey's Deitz, Ehlers Danlos [vascular subtype],
- pre-pregnancy diagnosis of pulmonary hypertension
- English- or Spanish-speaking
Exclusion Criteria:
- Unable to provide written informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Registry participant
Prospective collection of clinical information, completion of anxiety/depression, microaggressions, and quality of life questionnaires
|
all participants followed for clinical data for one year, vital status check at 5 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptive outcome: Outcomes
Time Frame: 5 years
|
Assess the maternal, neonatal and fetal outcomes of pregnancies affected by maternal cardiac disease
|
5 years
|
Descriptive outcome: morbidity and mortality
Time Frame: 5 years
|
Assess the maternal, fetal and neonatal morbidity and mortality associated with a pregnancy that is complicated by both congenital and acquired heart disease (see inclusion criteria for these definitions) through 5 years postpartum
|
5 years
|
Descriptive outcome: quality of life parameters
Time Frame: 1 year
|
Assess quality of life parameters during both gestation and the postpartum period in women with heart disease during pregnancy
|
1 year
|
Descriptive outcome: racial differences in maternal-fetal outcomes
Time Frame: 5 years
|
Describe racial differences in maternal - fetal outcomes
|
5 years
|
Descriptive outcome: outcomes and care pattern changes as a result of the COVID pandemic
Time Frame: 5 years
|
Assess the outcomes and care pattern changes as a result of the COVID pandemic for women with heart disease in pregnancy
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna Grodzinsky, MD, Saint Luke's Hospital
Publications and helpful links
General Publications
- Centers for Disease Control and Prevention. Pregnancy Mortality Surveillance System 2014. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pmss.htm
- www.Americanhealthrankings.org/explore/health-of-women-and-children/meaure/maternal_mortality/state/MO
- Blecker S, Paul M, Taksler G, Ogedegbe G, Katz S. Heart failure-associated hospitalizations in the United States. J Am Coll Cardiol. 2013 Mar 26;61(12):1259-67. doi: 10.1016/j.jacc.2012.12.038.
- Siu SC, Sermer M, Colman JM, Alvarez AN, Mercier LA, Morton BC, Kells CM, Bergin ML, Kiess MC, Marcotte F, Taylor DA, Gordon EP, Spears JC, Tam JW, Amankwah KS, Smallhorn JF, Farine D, Sorensen S; Cardiac Disease in Pregnancy (CARPREG) Investigators. Prospective multicenter study of pregnancy outcomes in women with heart disease. Circulation. 2001 Jul 31;104(5):515-21. doi: 10.1161/hc3001.093437.
- James AH, Jamison MG, Biswas MS, Brancazio LR, Swamy GK, Myers ER. Acute myocardial infarction in pregnancy: a United States population-based study. Circulation. 2006 Mar 28;113(12):1564-71. doi: 10.1161/CIRCULATIONAHA.105.576751. Epub 2006 Mar 13.
- Khairy P, Ouyang DW, Fernandes SM, Lee-Parritz A, Economy KE, Landzberg MJ. Pregnancy outcomes in women with congenital heart disease. Circulation. 2006 Jan 31;113(4):517-24. doi: 10.1161/CIRCULATIONAHA.105.589655.
- Drenthen W, Boersma E, Balci A, Moons P, Roos-Hesselink JW, Mulder BJ, Vliegen HW, van Dijk AP, Voors AA, Yap SC, van Veldhuisen DJ, Pieper PG; ZAHARA Investigators. Predictors of pregnancy complications in women with congenital heart disease. Eur Heart J. 2010 Sep;31(17):2124-32. doi: 10.1093/eurheartj/ehq200. Epub 2010 Jun 28.
- Ouyang DW, Khairy P, Fernandes SM, Landzberg MJ, Economy KE. Obstetric outcomes in pregnant women with congenital heart disease. Int J Cardiol. 2010 Oct 8;144(2):195-9. doi: 10.1016/j.ijcard.2009.04.006. Epub 2009 May 2.
- Liese KL, Mogos M, Abboud S, Decocker K, Koch AR, Geller SE. Racial and Ethnic Disparities in Severe Maternal Morbidity in the United States. J Racial Ethn Health Disparities. 2019 Aug;6(4):790-798. doi: 10.1007/s40615-019-00577-w. Epub 2019 Mar 15.
- Daymude AEC, Catalano A, Goodman D. Checking the pregnancy checkbox: Evaluation of a four-state quality assurance pilot. Birth. 2019 Dec;46(4):648-655. doi: 10.1111/birt.12425. Epub 2019 Mar 14.
- Lu MC. Reducing Maternal Mortality in the United States. JAMA. 2018 Sep 25;320(12):1237-1238. doi: 10.1001/jama.2018.11652. No abstract available.
- Wolfe DS, Hameed AB, Taub CC, Zaidi AN, Bortnick AE. Addressing maternal mortality: the pregnant cardiac patient. Am J Obstet Gynecol. 2019 Feb;220(2):167.e1-167.e8. doi: 10.1016/j.ajog.2018.09.035. Epub 2018 Sep 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOPE Pilot Registry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy Related
-
Helen Keller InternationalEleanor Crook FoundationNot yet recruitingPregnancy Related | Supplementation | Postnatal Related
-
4YouandMeCambridge Cognition Ltd; Sema4; Evidation Health; Vector Institute of Artificial... and other collaboratorsCompletedPregnancy Related | Wearables | Pregnancy EarlyUnited States
-
The University of Texas Health Science Center,...CompletedPregnancy Related | Pregnancy, High RiskUnited States
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Shaare Zedek Medical CenterUnknownPregnancy Related | Pregnancy, High Risk | Anesthesia
-
Ataturk UniversityNot yet recruiting
-
Medical College of WisconsinNot yet recruiting
-
University of PennsylvaniaNot yet recruiting
-
Centre for Infectious Disease Research in ZambiaWellcome Trust; Neopenda, PBCRecruiting
-
Emory UniversityNational Institute of Nursing Research (NINR)Recruiting
Clinical Trials on Observation
-
University of MichiganKuwait Foundation for the Advancement of SciencesCompletedGingival RecessionUnited States
-
Centre Hospitalier Régional d'OrléansCompleted
-
Istanbul University - Cerrahpasa (IUC)CompletedBrachial Plexus Palsy | Obstetric; InjuryTurkey
-
Abant Izzet Baysal UniversityRecruitingMultiple SclerosisTurkey
-
Universidad Autonoma de MadridCompleted
-
Universidad Autonoma de MadridUnknown
-
University of BergenEuropean Society of Intensive Care MedicineCompletedCritical Illness | Old Age; Debility | SurvivalNorway
-
Istanbul Medeniyet UniversityIstinye University; Ufuk UniversityRecruiting
-
IRCCS San Camillo, Venezia, ItalyUniversità Politecnica delle Marche; University of GenovaUnknown
-
Dokuz Eylul UniversityIzmir Katip Celebi UniversityCompleted