Actively Recruiting

Age: 18Years +
FEMALE
NCT03775954

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

543 weeks

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

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Current pregnancy complicated by one of the five diagnostic categories: prior unexplained stillbirth at or after 20 weeks gestation, fetal major congenital heart defect, fetal hydrops, fetal gastroschisis, or monochorionic twin pregnancy
  • Participant is 18 years of age or older
  • Participant speaks English and can read and sign the consent form in English
  • Participant can recline comfortably for 1 to 3 hours
  • Participant is willing to complete all three procedures (two fetal magnetocardiograms and one neonatal ECG) unless medically unable
  • Participant agrees to allow review of prenatal, delivery, and postnatal records to verify diagnosis and clinical findings
Not Eligible

You will not qualify if you...

  • Severe claustrophobia not improved by breaks, light, or having someone present
  • Active labor
  • Acute illness
  • Unable to recline comfortably with a pillow for more than 1 to 3 hours (with breaks)
  • Weight over 450 pounds
  • Use of an electric stimulation device (such as TENS unit, pacemaker, or nerve stimulator) that could interfere with recordings, although some devices may still qualify after discussion with study staff

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

G

Gretchen Eckstein

CONTACT

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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