Recruiting

Fetal Magnetocardiography

Sponsor:

Medical College of Wisconsin

Code:

NCT03775954

Conditions

High Risk Pregnancy

Congenital Heart Disease

Fetal Hydrops

Twin Monochorionic Monoamniotic Placenta

Gastroschisis

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fetal Magnetocardiogram and Neonatal Electrocardiogram

Substudy only: Maternal/Infant Pharmacogenomic assessment postnatally

Study Details

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.

Conditions

High Risk Pregnancy

Congenital Heart Disease

Fetal Hydrops

Twin Monochorionic Monoamniotic Placenta

Gastroschisis

Study ID

NCT03775954

Start date

Jul 1, 2018

Status verified date

Feb, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 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.

The subject will have a single 2-3 hour fetal magnetocardiogram at approximately 20 and 27 weeks GA, and again, if medical condition allows, between 30 and 37 weeks GA, then her infant will have an ECG between 0 and 4 weeks of age. Subjects will be paid a nominal fee for their participation each time, as well as transportation reimbursement if >25 miles. For subjects traveling a long distance, the ECG may be performed locally or at home.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

1) Fetal Congenital Heart Disease

Pregnancy with major fetal congenital heart disease, after 20 weeks gestation, and as neonate following delivery. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (nECG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.

2) History of fetal demise (Stillbirth)

Pregnancy with a history of an unexplained fetal demise (stillbirth at 20 -40 weeks gestation) during any prior pregnancy. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (nECG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.

3) Fetal hydrops, immune or non-immune

Pregnancy with fetal hydrops, immune or non-immune, at or after 20 weeks gestation. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (nECG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.

4) Fetal gastroschisis

Pregnancy with fetal gastroschisis, at or after 20 weeks gestation. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (nECG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.

5) Twin pregnancy, monochorionic

Twin pregnancy, monochorionic, with or without twin-twin transfusion syndrome, at or after 20 weeks gestation. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (fMCG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.

6) Maternal medications and Fetal Tachycardia

Mothers who are taking medications that impact QT interval, and/or are used to treat either a maternal risk of arrhythmi (Inherited arrhythmia Syndromes) or used for fetal tachycardia management are eligible for the substudy evaluating maternal and infant pharmacogenomics. PG will be measured after delivery by RPRD, Inc with results conveyed to the subject by the PI. The results are not used for clinical management of the pregnancy.

Interventions

Fetal Magnetocardiogram and Neonatal Electrocardiogram

Fetal Magnetocardiography (fMCG) is a new non-invasive diagnostic procedure that records tiny fetal cardiac signals similar to an Electrocardiogram or Holter monitor. The magnetometer has FDA clearance, and does not emit magnetic, electric or other energies. This is not an MRI. Examples of fetal MCG's can be found in the Links. The American Heart Association Scientific Statement on Fetal Diagnosis and Treatment (Circulation, 2014) has declared fMCG to be Class IIa for fetal heart rhythm abnormalities, meaning that benefit far exceeds risk. As part of this study, a neonatal electrocardiogram (nECG) will be obtained for comparison after the baby is born.

Substudy only: Maternal/Infant Pharmacogenomic assessment postnatally

See also section 6. Pharmacogenomics measure the way the liver breaks down medications. The systems controlling this are inherited, and mothers or infants can be normal, fast, ultrafast, or poor metabolizers for certain drugs. This study will attempt to improve future safety of cardiac drug treatments for both mother and fetus by evaluating the impact of PG.

Primary outcome measure

  • Heart rate variability using fMCG [ Time Frame: Comparison of procedures at approximately 20-27 weeks gestation, at 30-37 weeks gestation, and at neonatal ECG at 0-4 weeks of age ]
  • Cardiac conduction [ Time Frame: Comparison of cardiac time intervals at approximately 20-27 weeks gestation, 30-37 weeks gestation and at neonatal ECG at 0-4 weeks of age ]
  • Cardiac repolarization [ Time Frame: Comparison of cardiac repolarization at approximately 20-27 weeks gestation, 30-37 weeks gestation and neonatal ECG at 0-4 weeks of age. ]

Central Contacts and Locations

Central contacts

Mara C Koffarnus, MD

414-266-4758mkoffarn@mcw.edu

Gretchen Eckstein

414-266-3539geckstein@chw.org

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Ronald T Wakai, PhD

rtwakai@wisc.edu

Gretchen Eckstein, RN, BSN

414-266-3539geckstein@chw.org

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Janette F Strasburger, MD

414-266-2000jstrasbu@mcw.edu

Gretchen C Eckstein, RN, BSN

414-266-3539 (Preferred)geckstein@chw.org

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Mar 4, 2026

Last verified

Feb, 2026

Keywords

  • Fetal Magnetocardiography
  • Stillbirth
  • Intrauterine Fetal Demise
  • Fetal Heart Rate Variability
  • Fetal Arrhythmias
  • High Risk Pregnancy
  • Pregnancy
  • Fetal Anomaly
  • Fetal Echocardiography
  • Non-Stress Testing
  • New Technology
  • Birth Defects
  • Fetal Research

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-03-04.