跳至主要内容
临床试验/NCT04570124
NCT04570124已完成不适用

Implementing the Systemic Treatment and Management of Postpartum Hypertension (STAMPP-HTN) Bundle in a High-risk Mississippi Population

University of Mississippi Medical Center2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年12月14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
250
试验地点
2
主要终点
Determine if HBPT decreases the severity of postpartum hypertension complication

研究概览

简要总结

The purpose of this study is to determine if monitored blood pressure paired with education reduces maternal mortality and morbidity during the post-partum period in a high-risk rural population of women.

详细描述

Women with hypertension during pregnancy are at an increased risk of maternal mortality (death during or within 42 days of termination of pregnancy) and hypertension related morbidity. Black women, women with lower education and less access to health care resources also have increased maternal mortality and morbidity. This project will use Bluetooth enabled blood pressure devices to monitor blood pressure in a population of postpartum women at increased risk for maternal mortality and morbidity. We will compare the number of postpartum hypertensive incidences and severities to a population of women who did not have a postpartum blood pressure control intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Signed informed consent in a postpartum woman between 18-45 years of age at the time of study enrollment
  • Hospitalized for delivery with a hypertensive disorder of pregnancy as defined by ACOG 2019 Guidelines (chronic hypertension, HELLP syndrome, eclampsia, preeclampsia, gestational hypertension or new onset postpartum hypertension).
  • Ability to understand English or Spanish
  • Reliable access to the Internet and a Bluetooth mobile device
  • Willingness to download Omron Connect App and ability to use blood pressure monitor

排除标准

  • Does not meet Inclusion criteria
  • Postpartum or operative complication that prolongs hospital stay beyond postpartum day
  • Patients who are currently participating in another clinical trial to evaluate a therapeutic intervention for control of blood pressure.

结局指标

主要结局

Determine if HBPT decreases the severity of postpartum hypertension complication

时间窗: 9 months

Postpartum outcomes between women being monitored to those from the previous year who received no postpartum blood pressure monitoring will be compared. Women will be monitored and we measure Systolic, Diastolic and Mean arterial pressure and to see if HPBT decreases the severity of postpartum hypertension from previous baseline measurements from women who had no interventions. Percentages of patients with controlled blood pressure at each time point will be compared to previous BP measurements.

次要结局

  • Increase awareness and knowledge of postpartum blood pressure control in a group of high-risk women(9 months)
  • Assess compliance using HBPT and adherence to blood pressure medication(9 months)

研究者

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

Kedra Wallace

Associate Professor, PhD

University of Mississippi Medical Center

研究点 (2)

Loading locations...

相似试验