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

Summary

Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.

Conditions

• High Risk Pregnancy
• Congenital Heart Disease
• Fetal Hydrops
• Twin Monochorionic Monoamniotic Placenta
• Gastroschisis
• Fetal Demise
• Stillbirth
• Fetal Arrhythmia
• Long QT Syndrome
• Intrauterine Fetal Death
• Sudden Infant Death
• Pregnancy Loss
• Twin Twin Transfusion Syndrome
• Birth Defect
• Fetal Cardiac Anomaly
• Fetal Cardiac Disorder
• Fetal Death
• Brugada Syndrome
• Fetal Tachycardia

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.

GENETIC

Substudy only: Maternal/Infant Pharmacogenomic assessment postnatally

See also section 6. Pharmacogenomics measure the way the liver breaks down medications. The systems controlling this are inherited, and mothers or infants can be normal, fast, ultrafast, or poor metabolizers for certain drugs. This study will attempt to improve future safety of cardiac drug treatments for both mother and fetus by evaluating the impact of PG.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Wisconsin, Madison

  collaborator OTHER

• Tristan Technologies, Inc

  collaborator UNKNOWN

• Advancing a Healthier Wisconsin Endowment

  collaborator UNKNOWN

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Janette F Strasburger, MD · Medical College of Wisconsin

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2028-11-30

Completion

2028-11-30

Countries

• United States

Study Locations