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临床试验/NCT04714905
NCT04714905已完成不适用

Better Understanding the Metamorphosis of Pregnancy

4YouandMe1 个研究点 分布在 1 个国家目标入组 712 人开始时间: 2021年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
4YouandMe
入组人数
712
试验地点
1
主要终点
Study retention

研究概览

简要总结

Pregnancy is a commonly occurring medical event. Women who are pregnant may experience pregnancy-related symptoms and complications. However, there is a relative lack of multi-dimensional data on large populations of pregnant patients.

The Study Investigators aim to derive novel insights and deeper understanding of maternal physiology and pathology through the analysis of an unprecedented breadth and depth of data collected from connected devices (i.e., wearables, smart home scale, mobile apps, etc.), additional virtual study assessments and support calls, and information derived from standard of care clinical visits. They will share these insights to empower patients to better care for themselves.

The Investigators hope to know how leveraging the data collected from connected devices in addition to information obtained from routine clinical care helps researchers and clinicians better understand pregnancy related symptoms, conditions, and complications.

详细描述

During pregnancy a woman may experience symptoms that are specific to being pregnant, including nausea, fatigue, shortness of breath, insomnia etc. to much more complicated and serious symptoms. While pregnancy is a commonly occurring medical event that poses health risks to the pregnant woman and fetus, there is limited research on how to prevent and treat symptoms before they become higher risk complications. Utilizing mHealth technology for the collection of objective and subjective measurements and the integration of passive data (from connected devices) will increase understanding of pregnancy and subsequent complications and symptoms as indicative or predictive of particular outcomes.

In order to mitigate the risks of pregnancy, pregnant women are monitored closely and frequently through periodic in-clinic visits with their clinician. However, little is known about the progression of symptoms and measurements between clinic visits as continuous data is not collected as part of clinical practice.

Symptom trajectories have been historically characterized by sporadic visible data, insufficient to identify transition points. Visible data points are episodic and may (or may not) be captured by monthly clinical assessments during pregnancy, but invisible data points can be captured and more clearly defined through the use of longitudinal, passive data collection by wearing and connecting devices.

The Study Investigators aim to detect individual symptom transitions and shift trajectories of health to those which cannot be confined to the standard office clinical visit. They have selected devices which may help track the symptoms including The Oura Ring, the Garmin Venu Sq and the Bodyport scale. The study will follow women anticipating becoming pregnant and those pregnant up to and including 15 weeks.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant (up to and including 15 weeks) (Pregnancy cohort)
  • Anticipating to be pregnant (Pre-pregnancy cohort)
  • 18+ years (Pregnancy cohort)
  • 18-40 years (Pre-pregnancy cohort)
  • Has a personal cell phone that is an iPhone SE or newer or an Android device, version 6.0 or newer, and is willing to upgrade to the most recent operating system and use their phone for study (This includes a willingness to download and use the study applications and sync their phone with the necessary study devices)
  • Has an unshared email address
  • Proficient in English language

排除标准

  • Unable to read or understand the study materials
  • Does not have a permanent address
  • Intention to terminate pregnancy at the time of enrolment

结局指标

主要结局

Study retention

时间窗: 3-22 months

Proportion of participants completing the study Completion of 70% of data collection points (active tasks, surveys) per study participant. Correlations between objective sensor data with active measurements of pregnancy symptoms

Wearable device adherence

时间窗: 3-22 months

Average wearable device usage over study follow-up

App-based active task/survey adherence

时间窗: 3-22 months

Average daily active task and survey completion over study follow-up

次要结局

未报告次要终点

研究者

发起方
4YouandMe
申办方类型
Other
责任方
Sponsor

研究点 (1)

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