Fetal magnetocardiography: Using quantum technologies to define fetal rhythm, conduction, and repolarization prior to birth.
Janette F Strasburger
https://pubmed.ncbi.nlm.nih.gov/41126874Actively Recruiting
Age: 18Years +
FEMALE
ID03775954
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Led by Medical College of Wisconsin · Updated on 2026-03-04
30
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical College of Wisconsin
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on pregnancies at high risk for fetal demise, a tragic event where the fetus dies unexpectedly in the later stages of pregnancy. Researchers are studying five specific conditions linked to increased risk: major congenital heart defects in the fetus, fetal hydrops, monochorionic twin pregnancies, prior pregnancy loss due to fetal demise, and gastroschisis. The goal is to detect hidden heart rhythm abnormalities that might contribute to fetal demise by using a novel, non-invasive monitoring technique called fetal magnetocardiography (fMCG). The study involves detailed heart monitoring using fMCG at two points during pregnancy, approximately between 20-27 weeks and again between 30-37 weeks of gestation. After birth, a neonatal electrocardiogram (nECG) will be performed on the infant within the first 4 weeks of life. These assessments will measure heart rate variability, cardiac conduction, and repolarization patterns to identify any electrophysiological abnormalities. There is also a substudy evaluating how maternal and infant genetics affect medication metabolism related to heart rhythm treatments. Participants will undergo multiple procedures lasting 1 to 3 hours while reclining comfortably for the fMCG recordings. Researchers will compare the fetal heart monitoring results with neonatal ECG data and review medical records to confirm diagnoses and outcomes. The study aims to identify specific heart patterns that could predict fetal demise, helping to improve monitoring and care for high-risk pregnancies. Participants may receive compensation and travel reimbursement for their involvement, and local or home ECGs are available for those traveling long distances.
CONDITIONS
Brief Title
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant women with one of the following: prior unexplained stillbirth at or after 20 weeks gestation, major fetal congenital heart defect, fetal hydrops, fetal gastroschisis, or monochorionic twin pregnancy
- Age 18 years or older
- Able to read and sign consent form in English
- Able to recline comfortably for 1 to 3 hours
- Willing to complete two fetal magnetocardiograms and one neonatal electrocardiogram as per protocol
- Willing to allow review of prenatal, delivery, and postnatal records for diagnosis verification
You will not qualify if you...
- Severe claustrophobia not relieved by breaks, light, or company
- Active labor
- Acute illness
- Unable to recline comfortably with a pillow for 1 to 3 hours
- Weight over 450 pounds
- Use of electric stimulation devices like TENS units, pacemakers, or nerve stimulators that may cause interference with recordings
- Note: The magnetometer used does not emit energy, but some devices can interfere with measurements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - From approximately 20-27 weeks gestation to 30-37 weeks gestation
Participants undergo two fetal magnetocardiogram (fMCG) assessments during pregnancy to record fetal cardiac signals and assess heart rate, rhythm, and conduction patterns.
2 visits (in-person) during pregnancy
Long-term Monitoring
Duration - Up to 4 weeks after birth
Participants' newborns receive one neonatal electrocardiogram (nECG) to compare cardiac electrical patterns after birth and within the first 4 weeks of life.
1 visit (in-person) within 0-4 weeks of birth
Pharmacogenomic Assessment Substudy
Duration - Postnatal period
For participants in the substudy, maternal and infant pharmacogenomic testing is performed postnatally to evaluate inherited drug metabolism that may affect cardiac drug treatments.
1 visit (postnatal)
Trial Site Locations
Total: 2 locations
1
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53715
Actively Recruiting
2
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
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Research Team
M
Mara C Koffarnus, MD
G
Gretchen Eckstein
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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Published Research Related To This Trial
Diagnosis and treatment of fetal cardiac disease: a scientific statement from the American Heart Association.
Mary T Donofrio, Anita J Moon-Grady, Lisa K Hornberger...
https://pubmed.ncbi.nlm.nih.gov/24763516Fetal cardiac arrhythmia detection and in utero therapy.
Janette F Strasburger, Ronald T Wakai
https://pubmed.ncbi.nlm.nih.gov/20418904In utero diagnosis of long QT syndrome by magnetocardiography.
Bettina F Cuneo, Janette F Strasburger, Suhong Yu...
https://pubmed.ncbi.nlm.nih.gov/24218437Detection of Fetal Arrhythmia Using Optically-Pumped Magnetometers.
Margo Batie, Sarah Bitant, Janette F Strasburger...
https://pubmed.ncbi.nlm.nih.gov/29527577Complex and Novel Arrhythmias Precede Stillbirth in Fetuses With De Novo Long QT Syndrome.
Sarah Strand, Janette F Strasburger, Bettina F Cuneo...
https://pubmed.ncbi.nlm.nih.gov/32421437Low-Cost Fetal Magnetocardiography: A Comparison of Superconducting Quantum Interference Device and Optically Pumped Magnetometers.
Sarah Strand, William Lutter, Janette F Strasburger...
https://pubmed.ncbi.nlm.nih.gov/31394997Fetal Magnetocardiography Alters Diagnosis and Management in Fetal Congenital Heart Disease and Cardiomyopathy.
Annette Wacker-Gussmann, Janette F Strasburger, Ronald T Wakai
https://pubmed.ncbi.nlm.nih.gov/36137723Contribution of Fetal Magnetocardiography to Diagnosis, Risk Assessment, and Treatment of Fetal Arrhythmia.
Annette Wacker-Gussmann, Janette F Strasburger, Ronald T Wakai
https://pubmed.ncbi.nlm.nih.gov/35904205Fetal Arrhythmia Diagnosis and Pharmacologic Management.
Janette F Strasburger, Gretchen Eckstein, Mary Butler...
https://pubmed.ncbi.nlm.nih.gov/36106782