Home Monitoring of Fetal Heart Rhythm in Pregnancies of Anti-Ro/SSA Positive Women for the Treatment of Congenital Heart Block (FETAL HOPE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of fetal atrio-ventricular block evaluated as percentage of patients experiencing a fetal atrio-ventricular block.
研究概览
简要总结
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.
详细描述
The association between the transplacental passage of maternal autoantibodies against antigen A (Ro /SSA), common in autoimmune diseases such as Sjögren syndrome (SS) and systemic lupus erythematosus (SLE), and congenital heart block (CHB) has been established for some time.
Worldwide, approximately 0.5-1% of women of reproductive age are positive for anti-Ro/SSA antibodies, and in 1-2% of these women, pregnancy will be complicated by cardiac abnormalities of the fetus, particularly atrioventricular blocks (AVB) of various degrees.
Complete third-degree AVB occurs in 2-4% of fetuses exposed to anti-Ro/SSA, but up to one-third of cases show transient signs of first-degree AVB. Fetal irreversible complete AVB related to maternal Ro/SSA autoantibodies typically develops between weeks 20 and 24 of gestation. This condition has a mortality rate of 17-30%, is burdened by heavy cardiac pacing morbidity throughout the life of children born with AVB, and a high (10 times greater) risk of recurrence in subsequent pregnancies.
Some cases with CHB are preceded by first or second degree heart block. Treatment with steroids has also been suggested to prevent progression of first or second degree heart block to CHB, although the effect is controversial.
Complete or third-degree AVB appears to be irreversible, but anecdotal reports suggest that treatment of second-degree AVB can restore sinus rhythm. Unfortunately, weekly or biweekly fetal echocardiographic surveillance has only rarely detected AVB in time for treatment to be successful.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Incidence of fetal atrio-ventricular block evaluated as percentage of patients experiencing a fetal atrio-ventricular block.
时间窗: 8 months
Estimation of the incidence of fetal heart disease in pregnant patients with positive SSA autoantibodies
次要结局
- Home fetal heart rate monitoring reliability: percentage of patients reporting alterations of fetal heart rhythm detected by the hand-held fetal heart rate doppler.(5 months)
- Therapies' outcomes: percentage of patients where fetal atrio-ventricular block will be reverted by the use of individualized therapies.(8 months)
- Pregnancy outcome other than atrio-ventricular block reported as percentage of newborns presenting other symptoms of neonatal lupus, subgroup: hepatologic manifestations.(8 months)
- Pregnancy outcome other than atrio-ventricular block. Percentage of newborns presenting other symptoms of neonatal lupus, subgroup: haematologic manifestations.(8 months)
- Pregnancy outcome other than atrio-ventricular block. Percentage of newborns presenting other symptoms of neonatal lupus, subgroup: skin conditions.(8 months)
研究者
Dr Emanuele Bizzi
Medical Doctor
ASST Fatebenefratelli Sacco