What is this study trying to find out about high-risk pregnancies?

This study is evaluating hidden heart rhythm abnormalities in pregnancies at high risk for fetal demise. Researchers aim to identify specific heart patterns that may lead to fetal death in certain conditions, using a new non-invasive monitoring method called fetal magnetocardiography. The Medical College of Wisconsin is leading this research to improve monitoring and outcomes for affected pregnancies.

Who may be eligible for this high-risk pregnancy clinical trial?

Women who are 18 years or older and currently pregnant with one of several high-risk conditions, such as a prior unexplained stillbirth after 20 weeks, major fetal congenital heart defects, fetal hydrops, gastroschisis, or monochorionic twin pregnancy, may be eligible. Participants must be able to recline comfortably for the monitoring and speak English. Please review eligibility criteria for more details.

Is there any cost to participate in this high-risk pregnancy clinical trial?

Study-related care, including all monitoring procedures and trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Age: 18Years +

FEMALE

ID03775954

Monitoring Heart Electrical Activity in High-Risk Pregnancies to Detect Risks of Fetal Death Using Fetal Magnetocardiography and Neonatal ECG

Led by Medical College of Wisconsin · Updated on 2026-03-04

Participants Needed

Research Sites

N/A

Total Duration

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

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)