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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Normal

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

High-risk

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


Participant Flow:   Overall Study
    Normal   High-risk
STARTED   10   29 
COMPLETED   10   29 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Normal

pregnant women with uncomplicated pregnancies

magnetocardiography: recording of magnetic heart activity

fetal echocardiography: fetal echocardiography

High-risk

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 Total of all reporting groups

Baseline Measures
   Normal   High-risk   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   29   39 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Full Range)
 31.8 
 (28 to 35) 
 32.0 
 (24 to 42) 
 31.9 
 (24 to 42) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10 100.0%      29 100.0%      39 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   29   39 


  Outcome Measures

1.  Primary:   Percentage of Subjects Experiencing Symptoms   [ Time Frame: 15-40 weeks' gestation ]

2.  Primary:   Percentage of Subjects Experiencing Adverse Events Unrelated to Device   [ Time Frame: 15 weeks' gestation till up to 1 month after birth ]

3.  Primary:   Number of Participants With Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome   [ Time Frame: Birth to age 1 week ]

4.  Primary:   Percentage of Subjects Experiencing Adverse Events Related to Device   [ Time Frame: 15 weeks' gestation till up to 1 month after birth ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: rtwakai@wisc.edu



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