Clinical Research Directory
Browse clinical research sites, groups, and studies.
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Sponsor: Medical College of Wisconsin
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.
Official title: Fetal Electrophysiologic Abnormalities in High-risk Pregnancies Associated With Fetal Demise
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2018-07-01
Completion Date
2028-11-30
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (2)
University of Wisconsin - Madison
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States