Baseline characteristics.

High-risk pregnancies undergo regular antenatal monitoring, including cardiotocography (CTG) and ultrasound. Recently there has been an emergence of sophisticated remote telehealth interventions, potentially enabling care to be shifted into the home setting. Our aim was to evaluate the feasibility and acceptability of home CTG and home ultrasound monitoring for high-risk pregnancies. This was a single center study. Women aged ≥18 years, English speaking, singleton pregnancy, ≥ 32 weeks gestation and had at least one of four high-risk obstetric conditions were eligible. Participants were randomized to one of three groups: (1) home ultrasound; (2) home CTG; and (3) both, whilst continuing their routine antenatal care. The primary outcome was completion of 20 minutes of interpretable fetal heart recording and/or completion of an interpretable fetal ultrasound for each monitoring episode. Ultrasound interpretability was assessed for three validated criteria: fetal heartbeat, fetal movements and liquor volume assessment. Secondary outcomes included monitoring adherence, anxiety management, acceptability and safety. Fifteen participants, within three groups, completed 24 remote ultrasounds and 59 remote CTGs. Overall, the fetal heartbeat, movements and an assessment of the liquor volume were identified in 92%, 83% and 100% of all ultrasound scans respectively. 79% of all scans had all three criteria unanimously assessed. Three-quarters of all CTGs contained at least 20 minutes of continuous interpretable computerized fetal heartrate recording. Neither ethnicity, parity, BMI nor fetal presentation were significant factors for achievement of the primary outcome for both devices. There was non-significant reduction in anxiety scores before and after device usage (p = 0.19). Participants’ monitoring adherence and acceptability ratings were high in all groups. No adverse maternal-fetal outcomes relating to device usage occurred. Home ultrasound and cardiotocography are potentially feasible and acceptable to high-risk pregnant women. Larger studies are required to refine how best to implement such devices into clinical practice. ClinicalTrials ID: NCT06366711.

高危妊娠（high-risk pregnancy）需定期接受产前监测，涵盖胎心监护（cardiotocography, CTG）与超声（ultrasound）检查。近年来，各类先进的远程医疗（telehealth）干预手段不断涌现，有望将孕期护理延伸至家庭场景。本研究旨在评估高危妊娠群体采用家庭胎心监护与家庭超声监测的可行性与可接受性。本研究为单中心临床试验，符合纳入标准的受试者为年龄≥18岁、英语使用者、单胎妊娠（singleton pregnancy）、孕周≥32周，且至少存在4种高危产科病症（high-risk obstetric conditions）之一的女性。受试者被随机分为三组：(1)家庭超声监测组；(2)家庭胎心监护组；(3)联合监测组，所有受试者均需延续常规产前护理。主要结局指标为每次监测周期均完成20分钟可解读的胎儿心电记录，或完成可解读的胎儿超声检查。超声可解读性通过三项经过验证的标准进行评估：胎儿心跳、胎儿活动及羊水容量评估。次要结局指标包括监测依从性、焦虑管理情况、可接受性及安全性。三组共15名受试者完成了24次远程超声监测与59次远程胎心监护。总体而言，所有超声扫描中可识别胎儿心跳、胎儿活动及羊水容量评估的比例分别为92%、83%与100%；79%的超声扫描可同时满足三项评估标准。四分之三的远程胎心监护记录包含至少20分钟连续可解读的计算机化胎儿心率数据。受试者的种族、产次、身体质量指数（BMI）及胎儿先露方位均未对两种设备达成主要结局指标产生显著影响。受试者使用设备前后的焦虑评分虽有下降，但未达到统计学显著性（p=0.19）。所有组别的受试者监测依从性与可接受性评分均较高，且未出现与设备使用相关的母婴不良结局。家庭超声监测与胎心监护技术对高危妊娠群体而言具备潜在可行性与可接受性。未来需开展更大规模的研究，以优化此类设备在临床实践中的最佳应用方案。临床试验注册号：NCT06366711。