Validity and Feasibility of the Pregnancy Monitoring Belt - a Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- fetal heart rate
研究概览
简要总结
The aims of this clinical pilot study are to:
- to validate the following parameters: mother heart rate, mother ECG, fetal heart rate, contractions, mother oxygen saturation, mother breathing rate, mother blood pressure
- to evaluate the feasibility on detecting fetal movements
- to explore how pregnant women and health care professionals perceive the acceptability and usability of the pregnancy monitoring system
- to explore the possibility to support prenatal attachment between parent and fetus with remote pregnancy monitoring
The participating pregnant women will wear the pregnancy monitoring belt for 2 hours during of which, the data will be collected with pregnancy monitoring belt and patient monitor (reference device). The data from the pregnancy monitoring belt will be compared with the patient monitor data referred as golden standard. The acceptability and usability will be assessed by pregnant women and healthcare professionals by fulfilling a questionnaire and participating in interviews. The data collection will be conducted in hospital environment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •for pregnant women:
- •duration pf pregnancy at least 29+0 weeks
- •single pregnancy
- •age at least 18 years
- •ability to participate in Finnish No
排除标准
- •Inclusion criteria for healthcare professionals:
- •being a healthcare professional working with pregnant women
- •being able to participate in Finnish No exclusion criteria
研究组 & 干预措施
Pregnant women
Pregnant women wearing the pregnancy monitoring belt for two hours. In addition, the hospital patient monitor will be used to measure mother ECG, heart rate, breathing rate, oxygen saturation, blood pressure, contractions and fetal heart rate and movements.
Healthcare professionals
Healthcare professionals participating in the pregnancy care.
结局指标
主要结局
fetal heart rate
时间窗: Two hour data collection
Fetal heart rate will be measured with the sensorized pregnancy monitoring belt and to evaluate the accuracy of the measurements, the fetal heart rate measurements will be compared with the hospital patient monitor (golden standard).
次要结局
未报告次要终点
研究者
Anna Axelin
Professor
University of Turku