Monitoring fetal heart activity in high-risk pregnancies to prevent stillbirth
Fetal Electrophysiologic Abnormalities in High-risk Pregnancies Associated With Fetal Demise
Medical College of Wisconsin · NCT03775954
This study is testing a new way to monitor fetal heart activity in high-risk pregnancies to see if it can help prevent stillbirth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medical College of Wisconsin (other) |
| Locations | 2 sites (Madison, Wisconsin and 1 other locations) |
| Trial ID | NCT03775954 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate fetal electrophysiologic abnormalities in high-risk pregnancies associated with fetal demise using a novel non-invasive technique called fetal magnetocardiography (fMCG). The study focuses on five specific high-risk conditions, including major congenital heart disease and fetal hydrops, to identify potential hidden risks that could lead to stillbirth. Participants will undergo fMCG and neonatal electrocardiogram (nECG) assessments to gather data on fetal heart rate variability and other cardiac indicators. The goal is to improve fetal monitoring and potentially reduce the incidence of fetal demise by providing more accurate assessments than traditional methods.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 or older with a current pregnancy complicated by one of the specified high-risk conditions.
Not a fit: Patients who are in active labor or have severe claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques that significantly reduce the rate of stillbirth in high-risk pregnancies.
How similar studies have performed: While fetal magnetocardiography is a relatively novel approach, previous studies have shown promise in using similar non-invasive monitoring techniques to assess fetal health.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madison, Wisconsin and 1 other locations
- University of Wisconsin - Madison — Madison, Wisconsin, United States (RECRUITING)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Janette F Strasburger, MD — Medical College of Wisconsin
- Study coordinator: Mara C Koffarnus, MD
- Email: mkoffarn@mcw.edu
- Phone: 414-266-4758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: High Risk Pregnancy, Congenital Heart Disease, Fetal Hydrops, Twin Monochorionic Monoamniotic Placenta, Gastroschisis, Fetal Demise, Stillbirth, Fetal Arrhythmia