HOME(高危妊娠家庭监测)研究:一项远程医疗辅助在家随访与住院治疗的观察性研究方案。

IF 2.4 Q2 OBSTETRICS & GYNECOLOGY
Frontiers in global women's health Pub Date : 2025-07-14 eCollection Date: 2025-01-01 DOI:10.3389/fgwh.2025.1599153
Åsa Henning Waldum, Aase Serine Devold Pay, Gunvor Aasbø, Vinod Kumar Mishra, Meryam Sugulle, Anne Cathrine Staff
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引用次数: 0

摘要

背景:对母亲和后代有不良健康结局高风险的妊娠通常需要长期产前住院和/或频繁门诊。我们开发了一种高危妊娠远程监护家庭护理服务,并将其集成到我科的电子患者日志系统中。我们将比较临床安全性,患者报告的结果测量,以及与住院和/或门诊就诊的标准做法相比,医疗资源的使用。方法:高危妊娠家庭监测研究是一项持续的观察性研究。需要加强产科随访的符合条件的妊娠妇女(例如,早产胎膜早破、妊娠高血压疾病或既往不良产科结果),根据可用的家庭监测设备,将其纳入医院标准护理或家庭远程监测组的研究。纳入家庭监测的孕妇将根据住院患者的相关临床实践进行远程监测,包括使用心脏造影、血压监测、c反应蛋白、体温测量,并提供相关临床症状的自我登记。远程患者通信系统将在登记的不利临床参数或主观症状的情况下,迅速与医院联系。家庭远程监测的妇女将在个别指定的时间间隔到医院进行胎儿超声评估。在本研究中,接受住院治疗的患者作为对照组,接受标准治疗。主要结局是严重的孕产妇和围产期不良结局(败血症、子痫、脑出血、急性呼吸窘迫综合征、肝破裂、肺栓塞、羊水栓塞、溶血、肝酶升高、低血小板、无溶血的HELLP和弥散性血管内凝血)的综合结果,包括胎儿或新生儿死亡率、孕产妇死亡率和严重器官损伤的迹象。次要结局包括其他不良的孕产妇和胎儿/新生儿健康结局、患者报告的结局和经济成本分析。讨论:对需要加强监测的高危妊娠妇女实施家庭护理服务,对妇女来说同样安全,更舒适,更方便,经济成本更低。临床试验注册:Clinicaltrial.gov, NCT05763069。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

The HOME (home monitoring of high-risk pregnancies) study: a study protocol for an observational study of a telemedicine-assisted follow-up at home vs. hospitalization.

The HOME (home monitoring of high-risk pregnancies) study: a study protocol for an observational study of a telemedicine-assisted follow-up at home vs. hospitalization.

Background: Pregnancies at high risk for adverse health outcomes for mother and offspring often require long-term antenatal hospitalization and/or frequent outpatient visits. We have developed a telemonitoring home care service for high-risk pregnancies that has been integrated into the Electronic Patient Journal System of our department. We will compare clinical safety, patient-reported outcome measures, and use of healthcare resources compared to standard practice for hospital admissions and/or outpatient visits.

Method: The home monitoring of high-risk pregnancies study is an ongoing observational study. Eligible women with a pregnancy requiring intensified obstetric follow-up (e.g., preterm premature rupture of membranes, hypertensive disorders of pregnancy, or a previous adverse obstetric outcome) are offered study inclusion to either standard care at the hospital or the home telemonitoring group, depending on available home monitoring equipment. Pregnant women included for home monitoring will be telemonitored according to relevant clinical practice for inpatients, including the use of cardiotocography, blood pressure monitoring, C-reactive protein, and temperature measurement, and they will provide self-registration of relevant clinical symptoms. A telecare patient communication system will prompt rapid contact with the hospital in the case of unfavorable registered clinical parameters or subjective symptoms. The home telemonitored women will attend hospital visits for fetal ultrasound assessment at individually assigned intervals. Patients undergoing in-hospital care will serve as the control group in this study and receive standard care. The primary outcome is a composite of severe maternal and perinatal adverse outcomes (sepsis, eclampsia, cerebral hemorrhage, acute respiratory distress syndrome, liver rupture, pulmonary embolism, amniotic fluid embolism, hemolysis, elevated liver enzymes, low platelets, HELLP without hemolysis, and disseminated intravascular coagulation), including fetal or neonatal mortality, maternal mortality, and signs of severe organ damage. Secondary outcomes include other adverse maternal and fetal/neonatal health outcomes, patient-reported outcomes, and economic cost analyses.

Discussion: The implementation of a home care service for women with high-risk pregnancies requiring intensified surveillance is expected to be equally safe and more comfortable and convenient for the women, with lower economic costs.

Clinical trial registration: Clinicaltrial.gov, NCT05763069.

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