Health TrialsbyHealthPanel

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

ConditionsHigh Risk PregnancyCongenital Heart DiseaseFetal HydropsTwin Monochorionic Monoamniotic PlacentaGastroschisisFetal DemiseStillbirthFetal ArrhythmiaLong QT SyndromeIntrauterine Fetal DeathSudden Infant DeathPregnancy LossTwin Twin Transfusion SyndromeBirth DefectFetal Cardiac AnomalyFetal Cardiac DisorderFetal DeathBrugada SyndromeFetal Tachycardia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Current pregnancy complicated by one of the five diagnostic categories (fetal major congenital heart disease, prior unexplained Stillbirth at/after 20 weeks gestation, fetal hydrops, fetal gastroschesis, or monochorionic twin pregnancy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: 1) Fetal Congenital Heart Disease1 intervention
Group B: 2) History of fetal demise (Stillbirth)1 intervention
Group C: 3) Fetal hydrops, immune or non-immune1 intervention
Group D: 4) Fetal gastroschisis1 intervention
Group E: 5) Twin pregnancy, monochorionic1 intervention
Group F: 6) Maternal medications and Fetal Tachycardia1 intervention

Trial outcomes

Primary outcomes

1

Heart rate variability using fMCG

To measure and compare the fMCG heart rate variability in five pregnancy conditions associated with fetal demise, to those of gestation matched normal fetuses.

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
2

Cardiac conduction

To measure and compare the fMCG cardiac time intervals in five pregnancy conditions associated with fetal demise, to those of gestation matched normal fetuses and to neonatal ECGs at 0-4 weeks of age.

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
3

Cardiac repolarization

To measure and compare the fMCG cardiac repolarization patterns in five pregnancy conditions associated with fetal demise, to those of gestation matched normal fetuses, and to neonatal ECGs at 0-4 weeks of age.

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.

Secondary outcomes

1

Unique "signature" electrophysiologic abnormalities

2a) To determine whether unique "signature" electrophysiologic abnormalities are present in any of these five maternal-fetal diseases, and 2b) to define at what trimester these develop. Understanding any unique findings could allow study of specific treatment strategies in the future. findings are first seen.

Time frame
Comparison of findings at approximately 20-27 weeks gestation, 30-37 weeks gestation and neonatal ECG at 0-4 weeks of age
2

Pregnancy outcomes

To correlate fMCG findings with 3a) outcomes of pregnancies (fetal demise, premature delivery, small for GA, 5 minute APGAR \< 5, neonatal death) and 3b) fMCG cardiac time intervals with postnatal ECG intervals at 0-4 weeks of age.

Time frame
Comparison of findings at approximately 20-27 weeks gestation, 30-37 weeks gestation and neonatal ECG at 0-4 weeks of age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

University of Wisconsin, Madison

Collaborator

Tristan Technologies, Inc

Collaborator

Advancing a Healthier Wisconsin Endowment

Collaborator

Source ClinicalTrials.gov
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