Status:
COMPLETED
Fetal and Neonatal Magnetophysiology
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Shared Medical Technology, Inc.
Medical College of Wisconsin
Conditions:
Fetal Arrhythmia
Abnormality in Fetal Heart Rate or Rhythm
Eligibility:
FEMALE
18-60 years
Brief Summary
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, ...
Eligibility Criteria
Inclusion
- Normal subjects: normal, healthy adult women with uncomplicated pregnancies
- High-risk cohort: The primary inclusion criterion is diagnosis of serious fetal arrhythmia, which is defined as sustained low or high heart rate. Low heart rate, or bradycardia, and high heart rate, or tachycardia, are based on normative values for gestation (usually below 110 -120 beats/min, or above 160-180 beats/min). Intermittent bradycardia and tachycardia are also important to detect because these arrhythmias may become incessant over the course of pregnancy and have implications for patient management. Abnormal repolarization, such as long QT syndrome (LQTS), is another important class of arrhythmia. Fetuses with a family history of LQTS or a suspicious rhythm (low heart rate, intermittent AV block, or ventricular tachycardia) will also be studied.
Exclusion
- The pregnant women subjects must by aged 18 or older. High-risk subjects cannot participate if their physician in consultation with the lead physician of the study does not grant permission for them to participate in the study due to risk of travel or other reason.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01903564
Start Date
March 1 2014
End Date
June 1 2018
Last Update
May 29 2019
Active Locations (1)
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1
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705