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临床试验/NCT05763069
NCT05763069Enrolling By Invitation不适用

The HOME Study: Home Monitoring of High-risk Pregnancies

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
250
试验地点
1
主要终点
Feasibility of Home monitoring of high-risk pregnancies

研究概览

简要总结

High-risk pregnancies often require long-term hospitalization or outpatient maternal and/or fetal monitoring, placing a burden on patients, hospital resources and society. The demand for intensified pregnancy surveillance and interventions is increasing, due to the increased prevalence of risk factors like obesity and advanced maternal age, as well as altered guidelines resulting in increasing labor induction rates.The main aims of the HOME study (Home monitoring of pregnancies at risk) are to assess if home monitoring of selected high-risk pregnancies for maternal and fetal wellbeing is feasible, safe (in a clinical trial), cost-efficient, and simultaneously empowers the users.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Preeclampsia
  • Gestational Hypertension
  • Premature Preterm Rupture of Membranes
  • High Risk Pregnancy
  • Previous adverse obstetric outcomes

排除标准

  • Multiples (twins, triplets etc)
  • Patient or fetus in immediate need for delivery
  • Not understanding Norwegian
  • Not mastering the technological aspects of home monitoring
  • Long travel distance to Obstetric Department

结局指标

主要结局

Feasibility of Home monitoring of high-risk pregnancies

时间窗: 2022-2035

Development of secure data transfer systems from home to electronic patient records at the hospital

次要结局

  • Placenta-associated biomarkers: improving CTG prediction of adverse outcomes?(2023-2035)
  • Health economics of home monitoring(2022-2035)
  • User acceptability of home monitoring(2022-2035)
  • Clinical safety of home monitoring(2022-2035)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Cathrine Staff

Professor, Head of research, MD; PhD

Oslo University Hospital

研究点 (1)

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