Pregnant anti-SSA positive mothers are recruited at 16 to 18 weeks of gestation and taught how to use the Doppler fetal heart rate monitor. The multicenter** international observational study, which is still ongoing, is led by Bettina Cuneo, MD, former Director of Fetal Cardiology at the Colorado Fetal Care Center and Professor of Pediatrics and Obstetrics at the University of Colorado School of Medicine. All mothers will also undergo standard of care fetal echo surveillance ("office monitoring") and the two monitoring methods will be compared in the successful detection of emergent CAVB. Study authors proposed pregnant anti-SSA positive mothers use a commercially available Doppler fetal heart rate monitor* two times per day to detect the irregular rhythm of emergent CAVB ("home monitoring"). Continuous fetal monitoring from 18 to 25 weeks would be the true "gold standard" to detect this fleeting period of emergent CAVB, but this is unrealistic. An important barrier to progress in this field is the lack of a surveillance method to detect emergent CAVB and prevent progression to irreversible CAVB. However, if "emergent" CAVB – the time of irregular rhythm when the fetal heart is transitioning from normal rhythm to CAVB – is detected – transplacental treatment can restore sinus rhythm. To date, surveillance for emergent CAVB has been with weekly fetal echocardiograms, but since emergent CAVB develops in 24 hours, this technique has rarely been successful. Once established, CAVB is irreversible and either death or lifelong cardiac pacing is inevitable. In 4% of pregnancies, maternal anti-SSA antibodies cross the placenta at 18 weeks and cause inflammation and fibrosis of the fetal conduction system, resulting in complete atrioventricular block (CAVB) by 25 weeks. About 3% of all pregnant women carry an antibody called anti-SSA, or Sjogren’s antibody, which can be detected by a simple blood test.
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