RecruitingNCT05958446

Fetal-Hope Study: Home Monitoring of Fetal Heart Rate in SSA+ Pregnant Women

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


Sponsor

ASST Fatebenefratelli Sacco

Enrollment

200 participants

Start Date

Apr 14, 2022

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring the fetal heart rates of babies born to mothers with autoimmune antibodies (anti-Ro/SSA) during pregnancy. These antibodies can sometimes cause heart rhythm problems in the fetus, and this study uses a home monitoring device to detect these problems early so they can be treated promptly. **You may be eligible if...** - You are 18 or older and currently pregnant (or become pregnant during the study period) - You have tested positive for anti-Ro/SSA autoantibodies (associated with conditions like Sjogren's syndrome or lupus) **You may NOT be eligible if...** - There are no exclusion criteria listed for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

ASST Fatebenefratelli e Sacco

Milan, Italy

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NCT05958446


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