Home Monitoring of Fetal Heart Rhythm in Pregnancies of Anti-Ro/SSA Positive Women for the Treatment of Congenital Heart Block (FETAL HOPE)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Serological positivity for anti Ro-SSA antibodies is frequently found in pathologies such as Sjogren's Syndrome and SLE. Worldwide, approximately 0.5-1% of women of reproductive age are positive for Ro-SSA antibodies, and in 1-2% of these women, pregnancy will be complicated by cardiac abnormalities of the fetus, particularly varying degrees of atrioventricular block. It is essential to promptly identify patients with fetal heart rhythm abnormalities to prevent both intrauterine deaths and the birth of newborns with third-degree atrioventricular block, requiring lifelong cardiac pacing. At the moment, the only means to identify these alterations is represented by fetal cardiac ultrasound. Fetal atrioventricular block can develop within a few hours in these patients and fetal ultrasound, normally performed no more frequently than once every two weeks, does not allow for the timely identification of these conditions and therefore for pharmacological intervention. Using home fetal heart rate monitoring, carried out directly by patients three times a day with the aid of a special device that allows easy identification of the fetal heart rhythm, would allow rapid recognition of rhythm alterations and early access to confirmation tests and possible therapies. Fetal heart rhythm surveillance could detect a medically reversible disease that, if untreated, would progress to lifelong cardiac pacing, with its many associated comorbidities. Applying such protocol in pregnant women anti-Ro/SSA positive could become standard practice. The main objectives of this study are: * Estimation of the incidence of the development of fetal AV conduction abnormalities in patients with positivity for Ro/SSA autoantibodies; * Estimation of the reliability of home monitoring of fetal heart rate with fetal Doppler device in detecting fetal atrioventricular conduction disturbances; * Evaluation of the results of the therapy administered early, immediately after the diagnosis of fetal atrioventricular conduction disorders.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
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• All patients over the age of 18 will be enrolled in the study, who will sign the informed consent for participation in the study, characterized by the positivity of autoantibodies against Ro/SSA who will become pregnant during the enrollment period in the enrolling centres.

Locations
Other Locations
Italy
ASST Fatebenefratelli e Sacco
RECRUITING
Milan
Contact Information
Primary
Emanuele Bizzi, Dr
bizzi.emanuele@gmail.com
+393299636442
Backup
Antonio L Brucato, Prof
antonio.brucato@unimi.it
+390263632500
Time Frame
Start Date: 2022-04-14
Estimated Completion Date: 2026-04-14
Participants
Target number of participants: 200
Treatments
Pregnant women with SSA Auto Ab
All patients over the age of 18, who will sign the informed consent for participation in the study, characterized by the positivity of autoantibodies against Ro/SSA who will become pregnant during the enrollment period.
Sponsors
Leads: ASST Fatebenefratelli Sacco

This content was sourced from clinicaltrials.gov

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