Recruiting

Observational Study

Sponsor:

University of Missouri, Kansas City

Code:

NCT06517628

Conditions

Pregnancy Complications, Cardiovascular

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Purely observational study on the care and outcomes of participants with cardiovascular disease in pregnancy.

Study Details

Brief 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.

Conditions

Pregnancy Complications, Cardiovascular

Study ID

NCT06517628

Start date

Jan 14, 2025

Status verified date

Jan, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion:

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant people with cardiovascular disease

Any pregnant patient with acquired or congenital cardiovascular disease upon presentation to a cardio-obstetrics clinic.

Interventions

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 measure

  • Rate of Adverse pregnancy outcomes [ Time Frame: up to 6 weeks postpartum ]

Central Contacts and Locations

Central contacts

Karen L Florio, DO, MPH

631-579-1030klwa42@umsystem.edu

Anna Grodzinsky, MD, MS

816-932-2000agrodzinsky@saint-lukes.org

Locations

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Rosann Gans, RN, BSN

816-932-6122rgans@saint-lukes.org

Nancy Stone, MEd

8169325367nanstone@saint-lukes.org

Principal Investigator:

Anna Grodzinsky, MD

More Information

Sponsor

University of Missouri, Kansas City

Last update posted

Jan 20, 2025

Last verified

Jan, 2025

Keywords

  • Pregnancy, cardio-obstetrics
  • Structures of Care
  • Quality of Care
  • Disparities
  • Heart disease in pregnancy
  • Pregnancy complications
  • Adverse pregnancy outcomes
  • Major adverse cardiac events
  • Neonatal adverse events
  • Quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri, Kansas City on 2025-01-20.