The purpose of the research study “Heart Sounds at Home” is for pregnant SSA positive mothers using a home Doppler fetal heart rate monitor, to detect abnormal heart rates and rhythms in their babies before they are born.
The main procedures involved are: 1. Using the hand-held Doppler monitor to listen to your baby’s heart rate and rhythm twice daily from about 17-about 26 weeks of pregnancy.2. Call the primary investigator if the fetal heart rate or rhythm is abnormal. 3. Keep a log of the fetal heart rate and rhythm. 4. Undergo a fetal echocardiogram every 2 weeks between 17-26 weeks.
The exclusion criteria of the research study are: if you are less than 16 weeks or more than 18 6/7 weeks pregnant or you do not have SSA antibodies.
Compensation is not provided to participate in the study
The monitoring period is from the first visit at 17-18 weeks (before the SSA antibodies are thought to cross the placenta) to 25 weeks of gestation or when AV block develops (if it does develop)
The monitor is FDA approved for fetal heart rate detection, and is lent to you for the duration of the study. We teach you how to use the monitor at your first visit and are available during the day and by phone after 5:00 pm and weekends if you have questions.
In addition to the home monitoring, you will have a fetal echocardiogram every 2 weeks, which in many institutions is standard of care for pregnant women with SSA/SSB antibodies
Should you detect an irregular rhythm (skipped beats) or a fast (>180 beats per minute) or slow (<100 beats per minute) we ask that you call us so you can be evaluated to see if the baby is developing atrioventricular (AV) block.
If AV block is present, we discuss treatment options with you
If the fetal heart rate monitoring and fetal echocardiograms have been normal, no additional monitoring or testing is done unless your obstetrical care provider detects an abnormal heart rate or rhythm.
After your baby is delivered, we evaluate his/her heart rhythm evaluation with an electrocardiogram.
Lastly, to be certain that this study does not cause stress and anxiety, we ask you to fill out a standard stress/anxiety questionnaire at the beginning and end of the study period and again after the baby is born.
This is a multicenter international study which has been approved at the primary site (Children’s Hospital Colorado) by the Colorado Multiple Institutional Reveiw Board (#13-1879). Please contact the centers participating in the study (under the tab called “participating centers) as each center is responsible for IRB approval at their site.
If you need to contact the Colorado Multiple Instituional Review Board with any questions or concerns please call 303-724-1055 or email firstname.lastname@example.org