No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
30 (estimated)
Sponsor
Medical College of Wisconsin · Other
Who this trial is looking for
This trial is looking for pregnant individuals with certain high-risk conditions. Taking part involves having a non-invasive test to check the heart's activity of the fetus at specific times during pregnancy.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I am able to recline comfortably for 1-3 hours
I can read and sign the consent form in English
I have a current pregnancy with specific high-risk conditions
I am willing to let the study team review my medical records
You may not be able to join if
I am in active labor
I have severe claustrophobia not relieved by breaks or light
I have an acute illness
I weigh over 450 lbs
I cannot recline comfortably with a pillow for more than 1-3 hours
I have a device that causes electric or magnetic interference
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 elect…
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.
Trial Locations
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Status
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…
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.
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