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Fetal and Neonatal Magnetophysiology

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ClinicalTrials.gov Identifier: NCT01903564
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
Shared Medical Technology, Inc.
Medical College of Wisconsin
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Fetal Arrhythmia
Abnormality in Fetal Heart Rate or Rhythm
Long QT Syndrome
Interventions Device: magnetocardiography
Device: postnatal ECG
Device: fetal echocardiography
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal High-risk
Hide Arm/Group Description

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography: recording of magnetic heart activity

postnatal ECG: postnatal ECG

fetal echocardiography: fetal echocardiography

Period Title: Overall Study
Started 10 29
Completed 10 29
Not Completed 0 0
Arm/Group Title Normal High-risk Total
Hide Arm/Group Description

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography: recording of magnetic heart activity

postnatal ECG: postnatal ECG

fetal echocardiography: fetal echocardiography

Total of all reporting groups
Overall Number of Baseline Participants 10 29 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 29 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
29
 100.0%
39
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 29 participants 39 participants
31.8
(28 to 35)
32.0
(24 to 42)
31.9
(24 to 42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 29 participants 39 participants
Female
10
 100.0%
29
 100.0%
39
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 29 participants 39 participants
10 29 39
1.Primary Outcome
Title Percentage of Subjects Experiencing Symptoms
Hide Description Percentage of subjects experiencing symptoms
Time Frame 15-40 weeks' gestation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Symptoms include premature labor, vaginal bleeding, uterine cramping, nausea/vomiting, dizziness, dsypnea, syncope, palpitations, or fatigue during the study session.
Arm/Group Title Normal High-risk
Hide Arm/Group Description:

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography: recording of magnetic heart activity

postnatal ECG: postnatal ECG

fetal echocardiography: fetal echocardiography

Overall Number of Participants Analyzed 10 29
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Percentage of Subjects Experiencing Adverse Events Unrelated to Device
Hide Description Percentage of subjects experiencing adverse events unrelated to device
Time Frame 15 weeks' gestation till up to 1 month after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal High-risk
Hide Arm/Group Description:

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography: recording of magnetic heart activity

postnatal ECG: postnatal ECG

fetal echocardiography: fetal echocardiography

Overall Number of Participants Analyzed 10 29
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
10
  34.5%
3.Primary Outcome
Title Number of Participants With Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome
Hide Description Number of Participants with Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome based on measurement of rate-corrected QT interval (QTc)
Time Frame Birth to age 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Fetuses with a family history of long QT syndrome
Arm/Group Title Normal High-risk
Hide Arm/Group Description:

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography: recording of magnetic heart activity

postnatal ECG: postnatal ECG

fetal echocardiography: fetal echocardiography

Overall Number of Participants Analyzed 0 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
6
 100.0%
4.Primary Outcome
Title Percentage of Subjects Experiencing Adverse Events Related to Device
Hide Description Percentage of Subjects Experiencing Adverse Events Related to Device
Time Frame 15 weeks' gestation till up to 1 month after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal High-risk
Hide Arm/Group Description:

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography: recording of magnetic heart activity

postnatal ECG: postnatal ECG

fetal echocardiography: fetal echocardiography

Overall Number of Participants Analyzed 10 29
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Percentage of Fetuses With a Family History of Long QT Syndrome Who a Change in Diagnosis Due to fMCG
Hide Description Percentage of fetuses with a family history of long QT syndrome who a change in diagnosis due to fMCG
Time Frame 15 weeks' gestation to birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Fetuses with family history of LQTS
Arm/Group Title Normal High-risk
Hide Arm/Group Description:

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography: recording of magnetic heart activity

postnatal ECG: postnatal ECG

fetal echocardiography: fetal echocardiography

Overall Number of Participants Analyzed 0 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
3
  50.0%
6.Secondary Outcome
Title Percentage of Fetuses With a Family History of Long QT Syndrome Who Had a Change in Management Due to fMCG
Hide Description Percentage of fetuses with a family history of long QT syndrome who had a change in management due to fMCG
Time Frame 15 weeks' gestation to birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Fetuses with a family history of fetal long QT syndrome
Arm/Group Title Normal High-risk
Hide Arm/Group Description:

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography: recording of magnetic heart activity

postnatal ECG: postnatal ECG

fetal echocardiography: fetal echocardiography

Overall Number of Participants Analyzed 0 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
2
  33.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal High-risk
Hide Arm/Group Description

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

pregnant women with pregnancies complicated by fetal arrhythmia or the risk of fetal arrhythmia

magnetocardiography: recording of magnetic heart activity

postnatal ECG: postnatal ECG

fetal echocardiography: fetal echocardiography

All-Cause Mortality
Normal High-risk
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Normal High-risk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      2/29 (6.90%)    
Congenital, familial and genetic disorders     
fetal death * [1]  0/10 (0.00%)  0 1/29 (3.45%)  1
General disorders     
Motor vehicle accident * [2]  0/10 (0.00%)  0 1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
[1]
A fetus with a severe ion channelopathy died 10 days following participation in the study. The death is believed to be unrelated to the use of the device.
[2]
Subject was driving and was rear ended at high speed by another car. OB chose to admit her over night for observation for possibility of uterine contractions. No problem in-house, sent home <24 hours later.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Normal High-risk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/29 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ronald Wakai, Ph.D.
Organization: University of Wisconsin-Madison
Phone: 6082654988
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01903564     History of Changes
Other Study ID Numbers: 2013-0362
R01HL063174 ( U.S. NIH Grant/Contract )
First Submitted: July 11, 2013
First Posted: July 19, 2013
Results First Submitted: April 27, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018