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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT03775954
Status
Recruiting
Apply to this trial

Conditions

  • Birth Defect
  • Brugada Syndrome
  • Congenital Heart Disease
  • Fetal Arrhythmia
  • Fetal Cardiac Anomaly
  • Fetal Cardiac Disorder
  • Fetal Death
  • Fetal Demise
  • Fetal Hydrops
  • Fetal Tachycardia
  • Gastroschisis
  • High Risk Pregnancy
  • Intrauterine Fetal Death
  • Long QT Syndrome
  • Pregnancy Loss
  • Stillbirth
  • Sudden Infant Death
  • Twin Monochorionic Monoamniotic Placenta
  • Twin Twin Transfusion Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fetal Magnetocardiogram and Neonatal Electrocardiogram — DIAGNOSTIC_TEST
    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 — GENETIC
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2018
Status verified
Feb 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Wisconsin - MadisonMadisonWisconsin53715
Ronald T Wakai, PhD
[email protected]
Gretchen Eckstein, RN, BSN
[email protected]
414-266-3539
Medical College of WisconsinMilwaukeeWisconsin53226
Janette F Strasburger, MD
[email protected]
414-266-2000
Gretchen C Eckstein, RN, BSN
[email protected]
414-266-3539 (Preferred)

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