The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry

April 10, 2023 updated by: Saint Luke's Health System

The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry Pilot

Prospective US registry of pregnant women with cardiac disease to address the substantial gaps in knowledge surrounding these patients, in order to improve future care.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with cardiovascular disease

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anna Grodzinsky, MD, Saint Luke's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

December 30, 2026

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE Pilot Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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