A Study of Pregnancy Outcomes in Congenital Heart Disease

Pregnancy Outcomes in Patients With Adult Congenital Heart Disease

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06678256

Acronym

POACHD

Enrollment

Registered

2024-11-07

Start date

2026-01-01

Completion date

2026-11-01

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Brief summary

The purpose of this study is to determine if a biomarker assay obtained peripartum (1st-3rd trimester and post-partum) in patients with adult congenital heart disease can predict future risk of cardiovascular adverse events and determine if temporal changes in biomarkers levels throughout the peripartum period can provide a better risk prediction compared to samples taken at a single time-point.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Congenital Heart Disease Diagnosis * Currently Pregnant

Exclusion criteria

* Unable to consent

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects with cardiovascular adverse events	Baseline	A cardiovascular adverse event is defined as Documented atrial/ventricular arrhythmias, need for cardioversion, arrhythmia-related procedures (catheter ablation, implantation of pacemaker/defibrillator, anti-arrhythmia surgery), and heart failure hospitalization.

Secondary

Measure	Time frame	Description
Number of Subject Deaths	Baseline	Death will be determined as death due to end-stage heart failure, sudden cardiac death, thromboembolic death, and noncardiac death

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlexander Egbe, MBBS, MPH

Mayo Clinic

Outcome results