NCT03775954Recruiting
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 24 Oct 2018
- Start date
- 1 Jul 2018
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Medical College of Wisconsin
- NCT number
- NCT03775954
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Jul 2018 to the primary completion date, 30 Nov 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute illness
Age
- 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.
Other
- Severe claustrophobia not reduced by taking breaks, or by having the light on, or by having someone in the room with them.
- Active labor
- Unable to recline comfortably with a pillow for more than 1-3 hours (assuming some breaks are provided)
- Weight over 450 lbs
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.