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临床试验/NCT06576544
NCT06576544Enrolling By Invitation不适用

Evidence-Based Prediction and Prevention of Adverse Outcomes Caused by Postpartum Hypertension

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
1
主要终点
Postpartum blood pressure trends

研究概览

简要总结

To better understand postpartum blood pressure changes, the investigators are proposing a study to monitor blood pressure after delivery in 100 patients who the investigators expect to have normal blood pressure (i.e. low-risk group), 100 patients who the investigators expect to be at risk of new-onset high blood pressure postpartum (i.e. intermediate-risk group), and 100 patients who had high blood pressure prior to pregnancy (or very early, before 20 weeks in pregnancy) who the investigators know are at high risk of blood-pressure related complications postpartum (i.e. high-risk group). Patients will be given a non-invasive wearable device that monitors blood pressure continuously for 6 weeks postpartum. The investigators expect that the daily changes in blood pressure will be different between these groups, which may allow us to better predict who is at risk, how much monitoring is needed, and when to intervene before the blood pressure abnormalities cause complications. The blood pressure device that will be given to patients is the YHE® BP Doctor Med Blood Pressure Smartwatch. This is a highly-accurate medical grade device that has not received FDA clearance. As such, the device is not being used to make blood pressure management and treatment decisions, but rather to gather data on postpartum cardiovascular physiology. Safety stops are built into the protocol such that elevated readings detected by the watch will trigger clinical referrals and validation by standard blood pressure cuffs prior to determine need for treatment.

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

  • Postpartum birthing person 18 years of age or older
  • At least 20 weeks gestation at time of delivery
  • Meeting criteria for 1 of 3 risk categories for PP HTN and hypertensive morbidity
  • Planned postpartum care at UCSD

排除标准

  • Inability to give informed consent
  • Institutionalization for psychiatric disorder, mental deficiency or incarcerated
  • Initiation of antihypertensive therapy prior to discharge from delivery hospitalization.

结局指标

主要结局

Postpartum blood pressure trends

时间窗: 6 week postpartum period

Define the differences in longitudinal trends in blood pressure during the 6-week postpartum period between (a) subjects at low-risk for postpartum hypertension, (b) an intermediate-risk group, and (c) those at high-risk for postpartum hypertension.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ukachi Emeruwa

Assistant Professor

University of California, San Diego

研究点 (1)

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