跳至主要内容
临床试验/NCT03185455
NCT03185455已完成不适用

Remote Surveillance of Postpartum Hypertension

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2016年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
2
主要终点
Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge

研究概览

简要总结

Women with hypertensive disorders of pregnancy need postpartum blood pressure (BP) surveillance to detect persistent hypertension. Various barriers result in only 30% attendance at postpartum BP visits. A more effective strategy is needed. Women with hypertension of pregnancy will be randomized to either text-based monitoring or office visits. Those randomized to the intervention will receive a BP cuff and text in their BP to an automated, clinician derived, HIPAA compliant text-based algorithm.

详细描述

Hypertension is a leading cause of maternal morbidity, mortality and obstetrical readmissions. Peak blood pressure usually occurs 3-6 days postpartum, and is typically unaccompanied by warning symptoms. Although there is a clear need for effective and reliable blood pressure surveillance after delivery, there are significant obstacles to in-person visits in the immediate postpartum period, including sleep deprivation, newborn care, and transportation needs. These barriers have proven real as we observed only 30-50% attendance to office blood pressure visits following delivery. This proposal will investigate whether text-based communication between patients and providers is an effective alternative method for monitoring postpartum hypertension in at risk women.

Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • Women with chronic hypertension, gestational hypertension, or preeclampsia who deliver at the Hospital of the University of Pennsylvania will be eligible to participate. All patients must be > 18 years old, able to speak and read English, have a hypertension diagnosis, and have access to a cell phone with unlimited text message capabilities.

排除标准

  • Women without access to a cell phone with unlimited text message capabilities will be excluded from the study in order to eliminate barriers to participate in remote surveillance. However, we will track the number of women not eligible for this reason in order to understand generalizability in an urban population.

结局指标

主要结局

Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge

时间窗: 10 days postdischarge

the percentage of patients in which a single blood pressure is obtained in the first 10 days following discharge. Within the texting group, the percentage of patients in whom blood pressures values are obtained at 72 hours and 7-10 days postpartum, in accordance with American College of Obstetricians and Gynecologists recommendations, will be assessed as well.

次要结局

  • Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum(2 weeks postpartum)
  • Number of Participants Who Required Additional ER or Office Visits for Hypertension (Not Resulting in Readmission) Within 2 Weeks Postpartum(2 weeks postpartum)
  • Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum(2 weeks postpartum)
  • Patient Satisfaction(2 weeks postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Remote Surveillance of Postpartum Hypertension | 临床试验