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Observational Study of Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies

This observational study is looking for new ways to understand why some pregnancies end in fetal demise (when a baby dies in the womb). Researchers are using a non-invasive test called Fetal Magnetocardiography (fMCG) to measure your baby's heart signals. This test is similar to an EKG but for a baby in the womb and does not use radiation or emit energy. They are studying pregnant women who have a high-risk condition, such as a previous stillbirth, a baby with a major heart defect, fetal hydrops (fluid buildup in the baby), gastroschisis (a birth defect where the baby's intestines are outside the body), or a monochorionic twin pregnancy (identical twins sharing a placenta). The goal is to see if specific changes in the baby's heart rate, electrical signals, and recovery after each heartbeat, measured by fMCG and later by a neonatal EKG, can help identify potential problems. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an observational study, meaning researchers will watch and record information without giving any specific treatment. It plans to include 30 participants.
What's involved
You would undergo Fetal Magnetocardiography (fMCG) at approximately 20-27 weeks and 30-37 weeks gestation. Your baby would also have a Neonatal Electrocardiogram (ECG) at 0-4 weeks of age. There is also an optional substudy for maternal/infant pharmacogenomic assessment after birth.
Compensation
Not stated in the trial record.
Follow-up
Your baby's heart activity will be measured with a neonatal ECG at 0-4 weeks of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03775954

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

Recruiting
Not specifiedAges 18+Observational
Medical College of Wisconsin
~30 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Fetal Magnetocardiogram and Neonatal ElectrocardiogramSubstudy only: Maternal/Infant Pharmacogenomic assessment postnatally

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Heart rate variability using fMCG
Measured over Comparison of procedures at approximately 20-27 weeks gestation, at 30-37 weeks gestation, and at neonatal ECG at 0-4 weeks of age
+2 more outcomes measured

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
Fetal Tachycardia

Explore related trials

Congenital Heart DiseaseGastroschisisHigh Risk PregnancyHydrops FetalisMonochorionic twin pregnancyStillbirth

Where it's being run

2 sites across 1 states
Wisconsin2

Study leadership

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

Who to contact

Mara C Koffarnus, MD
[email protected]
414-266-4758
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Heart rate variability using fMCGComparison of procedures at approximately 20-27 weeks gestation, at 30-37 weeks gestation, and at neonatal ECG at 0-4 weeks of age

    To measure and compare the fMCG heart rate variability in five pregnancy conditions associated with fetal demise, to those of gestation matched normal fetuses.

  • Cardiac conductionComparison of cardiac time intervals at approximately 20-27 weeks gestation, 30-37 weeks gestation and at neonatal ECG at 0-4 weeks of age

    To measure and compare the fMCG cardiac time intervals in five pregnancy conditions associated with fetal demise, to those of gestation matched normal fetuses and to neonatal ECGs at 0-4 weeks of age.

  • Cardiac repolarizationComparison of cardiac repolarization at approximately 20-27 weeks gestation, 30-37 weeks gestation and neonatal ECG at 0-4 weeks of age.

    To measure and compare the fMCG cardiac repolarization patterns in five pregnancy conditions associated with fetal demise, to those of gestation matched normal fetuses, and to neonatal ECGs at 0-4 weeks of age.