About the Study
Enroll in the Study
Why are you doing this study?
We want to detect babies with LQTS before they are born
LQTS is difficult to detect before a baby is born
Most are not diagnosed until they have a serious symptom like cardiac arrest after birth
We have evidence that fetal heart rate can distinguish LQTS babies from babies who do not have LQTS
Recognizing LQTS before the baby is born:
Allows the baby to receive medication to treat life threatening heart rhythm problems
Does not expose the baby to medicines that could make the heart rhythm problem worse
Allows the baby to be born at a hospital that has experience with baby LQTS and a pediatric doctor who specializes in heart rhythm problems (a pediatric electrophysiologist)
What are the goals of your study?
We want to study heart rates of babies at risk for LQTS before they are born
In an earlier study we found the heart rates of LQTS babies before they are born are lower than babies who do not have LQTS
We would like to study fetal heart rates from very early in pregnancy until birth in families who have different LQTS mutations:
To see if the fetal heart rate can predict which baby will have LQTS
To see if patterns of fetal heart rate can predict whether the baby has LQTS1, LQTS2, or LQTS 3
Who can be part of the study?
Women who are currently pregnant between 7-20 weeks of gestation and either they or the baby’s father has LQTS 1, LQTS2, or LQTS3
Women who have been pregnant in the last 5 years and either they or the child’s father has LQTS 1, LQTS2, or LQTS3
Women currently pregnant or who have previously been pregnant and either they or the baby’s father have LQTS 1, LQTS2, or LQTS3
What Information do you collect from me?
Either the mother or father’s LQTS mutation
The symptoms of the LQTS parent
Who else in your family has LQTS?
What medications is the pregnant woman taking?
If the pregnant woman has LQTS, does she have a pacemaker or a defibrillator or both?
The number of times the mother has been pregnant and the outcomes of the pregnancies
The heat rates of the baby before birth that your OB care provider measures during your monthly visits
The heart rates of the baby before birth that are measured by ultrasounds routinely performed
The baby’s first ECG after birth
The results of the baby’s genetic testing (either positive or negative for LQTS)
I do not live near any of study sites. Can I still participate?
People can participate from anywhere in the world
Just send us your contact information and we will call/write/email you
You can give us your data via email/fax/phone/snail-mail or you can enter your own data from a computer into a “REDcap” data base that no one can see except you and the study team
Do I have to pay for anything?
You do not have to pay for anything to be part of this study
We are collecting information that is obtained as “standard of care”, that is, information collected from every pregnant women with LQTS or whose husband has LQTS
How long does the study go on?
If the baby has not yet been born, study participation begins when you enroll and ends when you report to us whether or not the baby has LQTS
If you already have children, study participation begins when you enroll, and ends when you have reported all the information about the baby/child/children to us
I am interested in hearing more and possibly enrolling in the study. What should I do?
Go to the “Contact Us” portion of the webpage and contact us!
You can call us, email us or give us your phone and email and we will contact you
You can ask for information and not participate in the study
We will not contact you unless you want us to
Who will see my information?
We take your confidentiality very seriously
Once you have signed a consent form to participate in the study, you become anonymous and identified by a number.
Only the principal investigators (Dr. Cuneo) know the identity of the numbers, and that information is in a password protected document known only to Dr. Cuneo
What will happen to the information you collect from me?
The information from all the participants (none of whom will be able to be identified) will be analyzed
The results will be presented in scientific meetings and published in a scientific journal.
Again, there will be no way to identify with you from the information presented
If you desire, we will share our results with you. Just contact us
Enroll in the Study