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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Wisconsin
University of Wisconsin - Madison
RECRUITING
Madison
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Mara C Koffarnus, MD
mkoffarn@mcw.edu
414-266-4758
Backup
Gretchen Eckstein
geckstein@chw.org
414-266-3539
Time Frame
Start Date: 2018-07-01
Estimated Completion Date: 2024-04-30
Participants
Target number of participants: 200
Treatments
1) Fetal Congenital Heart Disease
Pregnancy with major fetal congenital heart disease, after 20 weeks gestation, and as neonate following delivery. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (nECG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.
2) History of fetal demise (Stillbirth)
Pregnancy with a history of an unexplained fetal demise (stillbirth at 20 -40 weeks gestation) during any prior pregnancy. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (nECG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.
3) Fetal hydrops, immune or non-immune
Pregnancy with fetal hydrops, immune or non-immune, at or after 20 weeks gestation. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (nECG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.
4) Fetal gastroschisis
Pregnancy with fetal gastroschisis, at or after 20 weeks gestation. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (nECG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.
5) Twin pregnancy, monochorionic
Twin pregnancy, monochorionic, with or without twin-twin transfusion syndrome, at or after 20 weeks gestation. Two fetal magnetocardiograms (fMCG) and 1 neonatal electrocardiogram (fMCG) will be obtained and heart rate, rhythm, and conduction patterns will be compared.
Sponsors
Leads: Medical College of Wisconsin
Collaborators: Tristan Technologies, Inc, University of Wisconsin, Madison, Shared Medical Technology, Inc., Children's Hospital and Health System Foundation, Wisconsin, National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov