Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Fetal Electrophysiologic Abnormalities in High-risk Pregnancies Associated With Fetal Demise
Medical College of Wisconsin
30 participants
Jul 1, 2018
OBSERVATIONAL
Conditions
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
Inclusion Criteria11
- 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
- fetal gastroschisis
- monochorionic twin pregnancy
- Subject must be 18 years of age or older
- Subject must be English speaking and must be able to read and sign the consent form in English
- Subject must be able to recline comfortably for 1-3 hours
- Subject must be willing to complete all three procedures (fMCG, fMCG, nECG) as per protocol, unless medically unable
- Subject must be willing to allow us to review her and her infants prenatal, deliver, and post-natal records to verify diagnosis, and clinical findings.
Exclusion Criteria8
- 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)
- Weight over 450 lbs
- An electric stimulation device (TENS unit, pacemaker, or nerve stimulator) that could produce electric or magnetic noise.
- Note that the Tristan 624 Magnetometer does not pose a risk to the subject's device, (since fMCG does not produce any energy or magnetism), but stimulators themselves can cause interference for our recordings. Some devices may still qualify, and discussion with study nurse may be useful if subject has a pacemaker or similar device.
- The subject will have a single 2-3 hour fetal magnetocardiogram at approximately 20 and 27 weeks GA, and again, if medical condition allows, between 30 and 37 weeks GA, then her infant will have an ECG between 0 and 4 weeks of age. Subjects will be paid a nominal fee for their participation each time, as well as transportation reimbursement if \>25 miles. For subjects traveling a long distance, the ECG may be performed locally or at home.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03775954