NCT03775954 Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise

Trial Parameters

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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 * fetal gastroschisis * monochorionic twin pregnancy * Subject must be 18 years of age or older * Subject must be English speaking and must be able to read and sign the consent form in English * Subject must be able to recline comfortably for 1-3 hours * Subject must be willing to complete all three procedures (fMCG, fMCG, nECG) as per protocol, unless medically unable * Subject must be willing to allow us to review her and her infants prenatal, deliver, and post-natal records to verify diagnosis, and clinical findings. Exclusion Criteria: * 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

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