Status:
UNKNOWN
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Wisconsin, Madison
Conditions:
High Risk Pregnancy
Congenital Heart Disease
Eligibility:
FEMALE
18+ years
Brief 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...
Detailed Description
Fetal demise occurs in over 25,000 pregnancies annually in the US and over 2.5 million in pregnancies worldwide. Certain maternal-fetal-placental abnormalities can have a high risk of fetal demise. De...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03775954
Start Date
July 1 2018
End Date
April 30 2024
Last Update
November 3 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53715
2
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226