Fetal-hope study: Home monitoring of fetal heart rate in SSA plus pregnant women: Rationale and design

Introduction: Worldwide, approximately 0.5-1 % of women of childbearing age are positive for anti-Ro/SSA antibodies and anti-La/SSB. The presence of these antibodies may be responsible for the appearance of Neonatal Lupus. The pathogenesis of this disease is probably mediated by the binding of these antibodies to fetal myocardiocytes. The typical manifestation is atrioventricular block (AVB), which in most cases is complete (CHB). AVB commonly develops between 16 and 26 weeks of gestation and is cause of severe heart failure. CHB appears to be irreversible, but anecdotal reports suggest that treatment of second-degree AVB can restore sinus rhythm. Objective: The aim of the study is to evaluate the reliability of home monitoraing of fetal heart rate by the use of a hand-held device, extablishing the incidence of fetal AVB in pregnant women positive for anti-Ro/SSA autoantibodies and to evaluate whether early treatment can influence the course of the disease. Methods: Anti-Ro/SAA positive pregnant women are currently recruited from 11 Italian centers in a prospective observational study. Patients are instructed to use a portable doppler between 16 and 34 weeks of gestation and to monitor the fetal heart rate (FHR) every 8 h. In case of FHR anomalies patients will contact the reference center which will guarantee an echocardiogram within 8 h and in case of anomalies, adequate treatment. All patients will undergo check-ups at 20, 26 and 32 weeks of gestation, with the collection of information on the course of the maternal disease, on the use of drugs and on instrumental monitoring progress. After birth, data will be collected on the outcome of pregnancy and the methods of delivery. Newborns will also be evaluated for the possible appearance of clinical signs of Neonatal Lupus. Results: Fetal-Hope is actually enrolling Patients from involved Centers. Conclusions: Fetal-Hope is the first European study assessing the reliability of home monitoring of fetal heart rate using a handheld device, determining the incidence of fetal atrioventricular block (AVB) in pregnant women positive for anti-Ro/SSA autoantibodies and assessing whether early intervention can alter the disease's progression.