RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-07-01

Study Completion:2024-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03775954

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Mara C Koffarnus, MD

CONTACT

414-266-4758

mkoffarn@mcw.edu

Gretchen Eckstein

CONTACT

414-266-3539

geckstein@chw.org

Principal Investigator

Janette F Strasburger, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

University of Wisconsin - Madison

Madison, Wisconsin, 53715

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Janette F Strasburger, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-01

Study Completion Date2024-04-30

Study Record Updates