Last updated on December 2018

Prospective Maternal Surveillance of SSA (Sj gren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor

Brief description of study

The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjgren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.

Detailed Study Description

The study will enroll mothers during week 16-19 of gestation and will ask the mothers to use a hand-held Doppler monitor to listen to the baby's heart rate and rhythm twice daily from about week 16 to week 26 of the pregnancy. Pregnant mothers will be asked to keep a log of the heart rates and will undergo a fetal echocardiogram every 2 weeks during their study participation. In addition to these procedures, the study team will collect the mother's medical and obstetrical histories. Should irregular heart rhythms be detected at home, the mother will contact the investigator to be evaluated. After the baby is delivered, the study team will collect information about the baby's birth and heart rhythm evaluation (electrocardiogram).

Clinical Study Identifier: NCT02920346

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