About this trial
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.
Eligibility criteria
Qualifiers
Current pregnancy complicated by one of the five diagnostic categories
prior unexplained Stillbirth at/after 20 weeks gestation
fetal major congenital heart defect
fetal hydrops
Disqualifiers
Severe claustrophobia not reduced by taking breaks, or by having the light on, or by having someone in the room with them.
Active labor
Acute illness
Unable to recline comfortably with a pillow for more than 1-3 hours (assuming some breaks are provided)
Trial design
Treatments tested in this trial
- Fetal Magnetocardiogram and Neonatal Electrocardiogram
- Substudy only: Maternal/Infant Pharmacogenomic assessment postnatally
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Medical College of Wisconsin
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Wisconsin, Madison
Collaborator
Tristan Technologies, Inc
Collaborator
Advancing a Healthier Wisconsin Endowment
Collaborator