Trial Outcomes & Findings for Fetal and Neonatal Magnetophysiology (NCT NCT01903564)

Results Overview

Percentage of subjects experiencing symptoms

Recruitment status

COMPLETED

Target enrollment

39 participants

Primary outcome timeframe

15-40 weeks' gestation

Results posted on

2019-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	10	29
Overall Study COMPLETED	10	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fetal and Neonatal Magnetophysiology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal n=10 Participants pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	High-risk n=29 Participants 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 n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	29 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.8 years n=5 Participants	32.0 years n=7 Participants	31.9 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	29 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	29 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 15-40 weeks' gestation

Population: Symptoms include premature labor, vaginal bleeding, uterine cramping, nausea/vomiting, dizziness, dsypnea, syncope, palpitations, or fatigue during the study session.

Percentage of subjects experiencing symptoms

Outcome measures

Outcome measures
Measure	Normal n=10 Participants pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	High-risk n=29 Participants 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
Percentage of Subjects Experiencing Symptoms	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 15 weeks' gestation till up to 1 month after birth

Percentage of subjects experiencing adverse events unrelated to device

Outcome measures

Outcome measures
Measure	Normal n=10 Participants pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	High-risk n=29 Participants 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
Percentage of Subjects Experiencing Adverse Events Unrelated to Device	0 Participants	10 Participants

PRIMARY outcome

Timeframe: Birth to age 1 week

Population: Fetuses with a family history of long QT syndrome

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)

Outcome measures

Outcome measures
Measure	Normal pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	High-risk n=6 Participants 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
Number of Participants With Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome	0 Participants	6 Participants

PRIMARY outcome

Timeframe: 15 weeks' gestation till up to 1 month after birth

Percentage of Subjects Experiencing Adverse Events Related to Device

Outcome measures

Outcome measures
Measure	Normal n=10 Participants pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	High-risk n=29 Participants 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
Percentage of Subjects Experiencing Adverse Events Related to Device	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 15 weeks' gestation to birth

Population: Fetuses with family history of LQTS

Percentage of fetuses with a family history of long QT syndrome who a change in diagnosis due to fMCG

Outcome measures

Outcome measures
Measure	Normal pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	High-risk n=6 Participants 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
Percentage of Fetuses With a Family History of Long QT Syndrome Who a Change in Diagnosis Due to fMCG	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 15 weeks' gestation to birth

Population: Fetuses with a family history of fetal long QT syndrome

Percentage of fetuses with a family history of long QT syndrome who had a change in management due to fMCG

Outcome measures

Outcome measures
Measure	Normal pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	High-risk n=6 Participants 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
Percentage of Fetuses With a Family History of Long QT Syndrome Who Had a Change in Management Due to fMCG	0 Participants	2 Participants

Adverse Events

Normal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High-risk

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Normal n=10 participants at risk pregnant women with uncomplicated pregnancies magnetocardiography: recording of magnetic heart activity fetal echocardiography: fetal echocardiography	High-risk n=29 participants at 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
Congenital, familial and genetic disorders fetal death	0.00% 0/10	3.4% 1/29 • Number of events 1
General disorders Motor vehicle accident	0.00% 0/10	3.4% 1/29 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Ronald Wakai, Ph.D.

University of Wisconsin-Madison

Phone: 6082654988

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place