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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
High Risk Pregnancy
Intervention / Treatment

-

Contacts and Locations

Madison

University of Wisconsin - Madison, Madison, Wisconsin, United States, 53715

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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)
  • * Weight over 450 lbs
  • * An electric stimulation device (TENS unit, pacemaker, or nerve stimulator) that could produce electric or magnetic noise.
  • * Note that the Tristan 624 Magnetometer does not pose a risk to the subject's device, (since fMCG does not produce any energy or magnetism), but stimulators themselves can cause interference for our recordings. Some devices may still qualify, and discussion with study nurse may be useful if subject has a pacemaker or similar device.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical College of Wisconsin,

Janette F Strasburger, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

2024-04-30