胎儿希望研究：对 SSA + 孕妇进行胎儿心率的家庭监测：原理与设计

IF 2.1 4区医学 Q2 OBSTETRICS & GYNECOLOGY

European journal of obstetrics, gynecology, and reproductive biology Pub Date : 2024-10-06 DOI:10.1016/j.ejogrb.2024.10.009

A. Mauro , E. Bizzi , C. Caccia Dominioni , R. Milazzo , L. Serati , M. Nivuori , M. Quartarone , L. Bernardo , M.C. Gerardi , M. Fredi , I. Cetin , A.L. Brucato

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引用次数: 0

摘要

导言：全世界约有 0.5-1 % 的育龄妇女抗 Ro/SSA 抗体和抗 La/SSB 抗体呈阳性。这些抗体的存在可能是导致新生儿狼疮出现的原因。该病的发病机制可能是这些抗体与胎儿心肌细胞结合。典型的表现是房室传导阻滞（AVB），大多数情况下是完全性的（CHB）。房室传导阻滞通常发生在妊娠 16 至 26 周之间，是导致严重心力衰竭的原因。房室传导阻滞似乎是不可逆的，但轶事报道表明，治疗二度房室传导阻滞可以恢复窦性心律：本研究旨在评估使用手持式设备在家中监测胎儿心率的可靠性，确定抗Ro/SSA自身抗体阳性孕妇中胎儿房室传导阻滞的发生率，并评估早期治疗是否会影响病程：方法：目前，一项前瞻性观察研究从 11 个意大利中心招募了抗 Ro/SAA 阳性孕妇。患者被要求在妊娠 16 至 34 周期间使用便携式多普勒，每 8 小时监测一次胎儿心率（FHR）。如果 FHR 异常，患者将与参考中心联系，该中心将保证在 8 小时内进行超声心动图检查，如果异常，将进行适当治疗。所有患者都将在妊娠 20 周、26 周和 32 周时接受检查，收集有关产妇病程、药物使用和仪器监测进展的信息。分娩后，将收集有关妊娠结果和分娩方式的数据。还将对新生儿可能出现的新生儿红斑狼疮临床症状进行评估：结果：胎儿的希望正在招募相关中心的患者：Fetal-Hope 是欧洲的第一项研究，旨在评估使用手持设备在家中监测胎儿心率的可靠性，确定抗 Ro/SSA 自身抗体阳性孕妇中胎儿房室传导阻滞 (AVB) 的发生率，并评估早期干预是否能改变疾病的进展。

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Fetal-hope study: Home monitoring of fetal heart rate in SSA + 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.

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来源期刊

European journal of obstetrics, gynecology, and reproductive biology 医学-妇产科学

CiteScore

4.60

自引率

3.80%

发文量

898

审稿时长

8.3 weeks

期刊介绍： The European Journal of Obstetrics & Gynecology and Reproductive Biology is the leading general clinical journal covering the continent. It publishes peer reviewed original research articles, as well as a wide range of news, book reviews, biographical, historical and educational articles and a lively correspondence section. Fields covered include obstetrics, prenatal diagnosis, maternal-fetal medicine, perinatology, general gynecology, gynecologic oncology, uro-gynecology, reproductive medicine, infertility, reproductive endocrinology, sexual medicine and reproductive ethics. The European Journal of Obstetrics & Gynecology and Reproductive Biology provides a forum for scientific and clinical professional communication in obstetrics and gynecology throughout Europe and the world.