Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Correlation between the physiology and the menstrual cycle dynamics
研究概览
简要总结
In this study physiological data is measured using wearable sensors as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with regular cycles, who aim for a spontaneous pregnancy. These women were recruited to generate reliable data on changes of the measured physiological parameters in a healthy menstrual cycle, as well as to evaluate physiological changes associated with early pregnancy.
All pregnancies beginning during the study period are to be monitored to their natural end, in order to evaluate how the same nine physiological parameters are changing during pregnancy, how strong the variations of the parameters during pregnancy are, and whether they could be associated with early onsets of pregnancy complications such as premature birth or pre-eclampsia. This will be highly valuable to develop study protocols for the specific evaluation of the screening potential of pregnancy complications.
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
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged 20-40 years
- •regular menstrual cycle (28 days+/-)
- •no hormonal therapy
- •German-speaking
- •written informed consent to participate in the study
排除标准
- •any health-related issues that may affect menstrual cycle
- •any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated
- •frequent travel between time zones
- •sleeping disorders
- •unsuccessfully trying to conceive for > 12 months
结局指标
主要结局
Correlation between the physiology and the menstrual cycle dynamics
时间窗: November 2016 - November 2020
Correlation between a the following physiological parameters (individually or in combination), pulse rate, respiration, skin conductance response, sleep duration and quality, and skin perfusion with the menstrual cycle dynamics
次要结局
- Correlation between physiology and pregnancy complications(November 2016 - November 2020)
- Correlation between the physiology measured using a wearable device and the occurrence of pregnancy(November 2016 - November 2020)
