RecruitingNCT03775954

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

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

Sponsor

Medical College of Wisconsin

Enrollment

30 participants

Start Date

Jul 1, 2018

Study Type

OBSERVATIONAL

Conditions

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

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special type of heart monitoring technology called fetal magnetocardiography (fMCG) to detect electrical abnormalities in the hearts of unborn babies in high-risk pregnancies. The heart monitor is completely non-invasive and safe — it simply detects tiny magnetic signals from the fetal heart without emitting any radiation or energy. The goal is to find out if certain abnormal heart rhythms in the fetus can predict which babies are at risk for serious complications, including stillbirth. This study is open to pregnant women who have one of five high-risk pregnancy conditions: a previous unexplained stillbirth, a fetus with a major congenital heart defect, fetal hydrops, fetal gastroschisis, or a monochorionic twin pregnancy. Participating involves reclining comfortably for 1–3 hours at around 20, 27, and 30–37 weeks of pregnancy, as well as an ECG for the baby after birth. You may be eligible if: - You are 18 or older and currently pregnant - Your pregnancy is affected by one of the five qualifying conditions - You are English-speaking and able to sign a consent form - You are able to recline comfortably for 1–3 hours You may NOT be eligible if: - You have severe claustrophobia that cannot be managed - You are currently in active labor or have an acute illness - You weigh over 450 lbs - You have an electric stimulation device (like a TENS unit or pacemaker) that could interfere with recordings Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFetal Magnetocardiogram and Neonatal Electrocardiogram

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.

GENETICSubstudy only: Maternal/Infant Pharmacogenomic assessment postnatally

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.