Pardo Anat, Kalafat Erkan, Hazon Shira, Pailis Monica, Klochendler-Frishman Emilie, Rak Or Lee, Samueloff Ofri, Gomez-Tolub Rachel, Shmueli Anat, Pardo Noam, Sela Tomer, Wolff Leor, Walfisch Asnat, Wiznitzer Arnon, Hadar Eran
Helen Schneider Hospital for Women, Rabin Medical Center, 39 Jabotinsky Street, Petach-Tikva, 4941492, Israel.
Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.
BMC Pregnancy Childbirth. 2025 Jul 2;25(1):691. doi: 10.1186/s12884-025-07664-3.
Telehealth solutions, including ultrasound technology, are sought as a modality to enhance prenatal. We aimed to evaluate the utilization of a self-operated home ultrasound service in a real-world large cohort, comparing users vs. non-users. This service provides a handheld, app-connected ultrasound device for remote basic fetal monitoring, with its use determined at the discretion of the patient as a supplement - rather than a replacement - to standard prenatal care.
Retrospective analysis comparing maternal and neonatal outcomes among users versus non-users of the home ultrasound service, between January 2020 and December 2022. Primary outcome measures were preterm delivery and a composite adverse neonatal outcome. Confounders were balanced between the groups using nearest neighbour matching with propensity scores. Multivariable analyses including the confounders were conducted in matched cohorts to obtain doubly robust estimates. A sensitivity analysis included those who began using the device before 22 gestational weeks and continued for more than 10 weeks. Safety was assessed by identifying any maternal, obstetrical, or neonatal complications plausibly linked to device use.
The study compared two cohorts; the exposed cohort of 4,460 pregnant women using Clalit's home ultrasound service (users), and the control (non-users) cohort of 102,707 pregnant women with an equal HMO insurance status. Users had higher socioeconomic scores, were more primiparous and had a higher incidence of chronic disease and pregnancy complications. Preterm birth rates and adverse neonatal outcomes did not differ between groups. Device utilization, both overall and stratified by actual utilization degree, was safe and not associated with any maternal, obstetrical or neonatal adverse pregnancy outcomes.
A self-operated home ultrasound device, during the second and third trimester, is safe and not significantly associated with any pregnancy adverse event or neonatal complications.
包括超声技术在内的远程医疗解决方案被视为一种增强产前检查的方式。我们旨在评估一项自行操作的家庭超声服务在一个真实世界的大型队列中的使用情况，比较使用者与非使用者。这项服务提供一种手持式、通过应用程序连接的超声设备，用于远程基本胎儿监测，其使用由患者自行决定，作为标准产前护理的补充而非替代。
对2020年1月至2022年12月期间家庭超声服务的使用者与非使用者的母婴结局进行回顾性分析。主要结局指标为早产和复合不良新生儿结局。使用倾向评分的最近邻匹配法在两组之间平衡混杂因素。在匹配队列中进行包括混杂因素的多变量分析，以获得双重稳健估计。敏感性分析包括那些在妊娠22周前开始使用该设备并持续使用超过10周的人。通过识别任何可能与设备使用相关的母体、产科或新生儿并发症来评估安全性。
该研究比较了两个队列；暴露队列是4460名使用克拉利特家庭超声服务的孕妇（使用者），对照（非使用者）队列是102707名具有相同健康维护组织保险状态的孕妇。使用者的社会经济得分更高，初产妇更多，慢性病和妊娠并发症的发生率更高。两组之间的早产率和不良新生儿结局没有差异。设备的总体利用率以及按实际使用程度分层的利用率都是安全的，并且与任何母体、产科或新生儿不良妊娠结局无关。
在妊娠中期和晚期，自行操作的家庭超声设备是安全的，与任何妊娠不良事件或新生儿并发症均无显著关联。
