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

Launched by MEDICAL COLLEGE OF WISCONSIN · Dec 13, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor the heart activity of unborn babies in high-risk pregnancies. Each year, many babies die unexpectedly in the later stages of pregnancy, often due to hidden heart issues. The researchers want to use a non-invasive method called fetal magnetocardiography (fMCG) to identify these potential problems early in five specific high-risk pregnancy situations, such as when there’s a major heart defect or previous stillbirth.

To be eligible for this trial, participants should be women aged 18 or older who are currently pregnant and have one of the five conditions mentioned. They must also be able to lie comfortably for a few hours during the tests. If you join the study, you'll undergo a couple of fMCG sessions during your pregnancy, and your baby will have a heart test shortly after birth. Participants will receive a small payment for their time and can get help with travel costs if needed. Overall, this study aims to improve the understanding and monitoring of babies at risk for heart issues, potentially preventing future tragedies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.