Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, London, UK.
Department of Obstetrics and Gynaecology, Monash University, Victoria, Australia.
J Matern Fetal Neonatal Med. 2023 Dec;36(1):2204390. doi: 10.1080/14767058.2023.2204390.
Antenatal fetal heart rate (FHR) monitoring is currently limited by hospital-based accessibility as well as the availability of relevant equipment and expertise required to position device electrodes. Ambulatory FHR monitoring in the form of noninvasive fetal electrocardiography (NIFECG) is currently an area of research interest, particularly during the era of the COVID-19 pandemic, and the potential to improve maternity care and reduce hospital attendances need to be evaluated.
To assess the feasibility, acceptability, and signal success of ambulatory NIFECG monitoring and identify research areas required to facilitate clinical utilization of this method of monitoring.
Medline, EMBASE, and PubMed databases were searched from January 2005 to April 2021 using terms relevant to antenatal ambulatory or home NIFECG. The search was compliant with PRISMA guidelines, and was registered with the PROSPERO database (CRD42020195809). All studies reporting the clinical utilization of NIFECG inclusive of its use in the ambulatory setting performed in the antenatal period, human studies, and those in the English language were included. Those reporting novel technological methods and electrophysiological algorithms, satisfaction surveys, intrapartum studies, case reports and reviews, and animal studies were excluded. Study screening and data extraction were conducted in duplicate. Risk of bias was appraised using the Modified Downs and Black tool. Due to the heterogeneity of the reported findings, a meta-analysis was not feasible.
The search identified 193 citations, where 11 studies were deemed eligible for inclusion. All studies used a single NIFECG system with a duration of monitoring ranging from 5.6 to 21.4 h. Predefined signal acceptance threshold ranged from 34.0-80.0%. Signal success in the study populations was 48.6-95.0% and was not affected by maternal BMI. Good signals were achieved in the 2nd trimester, but less so in the early 3rd trimester. NIFECG was a well-accepted method of FHR monitoring, with up to 90.0% of women's satisfaction levels when worn during outpatient induction of labor. Placement of the acquisition device needed input from healthcare staff in every report.
Although there is evidence for the clinical feasibility of ambulatory NIFECG, the disparity in the literature limits the ability to draw firm conclusions. Further studies to establish repeatability and device validity, whilst developing standardized FHR parameters and set evidence-based standards for signal success for NIFECG are required to ascertain the clinical benefit and potential limitations of ambulatory outpatient FHR monitoring.
目前，产前胎儿心率（FHR）监测受到医院可及性以及放置设备电极所需的相关设备和专业知识的限制。非侵入性胎儿心电图（NIFECG）形式的动态 FHR 监测目前是一个研究热点，尤其是在 COVID-19 大流行期间，需要评估改善产妇护理和减少医院就诊的潜力。
评估动态 NIFECG 监测的可行性、可接受性和信号成功率，并确定促进该监测方法临床应用所需的研究领域。
使用与产前动态或家庭 NIFECG 相关的术语，从 2005 年 1 月至 2021 年 4 月在 Medline、EMBASE 和 PubMed 数据库中进行搜索。该搜索符合 PRISMA 指南，并在 PROSPERO 数据库（CRD42020195809）中进行了注册。所有报告 NIFECG 临床应用的研究，包括在产前进行的动态或家庭 NIFECG 应用，均为人类研究，且为英文研究。排除报告新型技术方法和电生理算法、满意度调查、分娩期研究、病例报告和综述以及动物研究的报告。研究筛选和数据提取均由两人进行。使用改良的 Downs 和 Black 工具评估偏倚风险。由于报告结果的异质性，因此无法进行荟萃分析。
搜索确定了 193 条引文，其中有 11 项研究被认为符合纳入标准。所有研究均使用单一的 NIFECG 系统，监测时间从 5.6 至 21.4 小时不等。预定义的信号接受阈值范围为 34.0-80.0%。研究人群中的信号成功率为 48.6-95.0%，且不受母体 BMI 的影响。在孕中期可以获得良好的信号，但在孕早期则信号较差。NIFECG 是一种可接受的 FHR 监测方法，当在门诊引产期间佩戴时，高达 90.0%的女性表示满意。采集设备的放置需要医护人员的输入，这在每一份报告中都有体现。
尽管有证据表明动态 NIFECG 具有临床可行性，但文献中的差异限制了得出明确结论的能力。需要进一步研究以确定重复性和设备有效性，同时制定标准化的 FHR 参数和基于证据的 NIFECG 信号成功标准，以确定动态门诊 FHR 监测的临床益处和潜在局限性。
