Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

July 1, 2018

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2024

Conditions
High Risk PregnancyCongenital Heart DiseaseFetal HydropsTwin Monochorionic Monoamniotic PlacentaGastroschisisFetal DemiseStillbirthFetal ArrhythmiaLong QT SyndromeIntrauterine Fetal DeathSudden Infant DeathPregnancy LossTwin Twin Transfusion SyndromeBirth DefectFetal Cardiac AnomalyFetal Cardiac DisorderFetal DeathBrugada Syndrome
Interventions
DIAGNOSTIC_TEST

Fetal Magnetocardiogram and Neonatal Electrocardiogram

Fetal Magnetocardiography (fMCG) is a new non-invasive diagnostic procedure that records tiny fetal cardiac signals similar to an Electrocardiogram or Holter monitor. The magnetometer has FDA clearance, and does not emit magnetic, electric or other energies. This is not an MRI. Examples of fetal MCG's can be found in the Links. The American Heart Association Scientific Statement on Fetal Diagnosis and Treatment (Circulation, 2014) has declared fMCG to be Class IIa for fetal heart rhythm abnormalities, meaning that benefit far exceeds risk. As part of this study, a neonatal electrocardiogram (nECG) will be obtained for comparison after the baby is born.

Trial Locations (2)

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

53715

RECRUITING

University of Wisconsin - Madison, Madison

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

University of Wisconsin, Madison

OTHER

collaborator

Children's Hospital and Health System Foundation, Wisconsin

OTHER

collaborator

Shared Medical Technology, Inc.

INDUSTRY

collaborator

Tristan Technologies, Inc

UNKNOWN

lead

Medical College of Wisconsin

OTHER