Electrophysiology of Fetal Arrhythmia
ConditionFetal Arrhythmia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
Fetal research and clinical practice has been hampered by a lack of suitable investigational techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy and physiology, but it has significant limitations for assessment of cardiac rhythm. The proposed study will allow the investigators to evaluate fetal magnetocardiography (fMCG) as a new tool for the study of normal and abnormal fetal heart rate and rhythm.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
uncomplicated pregnancy at gestational age >12 weeks
pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age >15 weeks
Disqualifiers
uncomplicated pregnancy <12 weeks gestation
pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age <15 weeks
Trial population
Uncomplicated pregnancies and pregnancies complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
fetal MCG
Deviceassess fetal heart rate and rhythm
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: High-risk pregnancy1 intervention
Group B: Uncomplicated pregnancy1 intervention
Trial outcomes
Primary outcomes
1
Rhythm assessment
fetal MCG rhythm assessment
Time frame
after 15 weeks gestationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov