Monitoring fetal heart activity in high-risk pregnancies to prevent stillbirth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.