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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMedical College of Wisconsin

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

30 Participants
are divided into 6 treatment groups

6

Treatment groups

See 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