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临床试验/NCT05631067
NCT05631067已完成不适用

Feasibility and Acceptability of Remote Blood Pressure Monitoring and Risk Stratification in the Fourth Trimester to Reduce Maternal Cardiovascular Morbidity and Mortality in Nigeria

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年10月15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
180
试验地点
1
主要终点
Rate of recruitment

研究概览

简要总结

Hypertensive disorders of pregnancy (HDP) are major causes of maternal morbidity and mortality globally and are associated with peripartum and future cardiovascular disease, including stroke, heart failure, and myocardial infarction. About 1 out of every 10 maternal deaths in Sub-Saharan Africa are associated with HDP, and most of these deaths are preventable with timely, implementation of evidence-based strategies, including postpartum blood pressure (BP) monitoring, treatment of elevated BP and comprehensive postpartum follow up as recommended by the American College of Obstetricians and Gynecologists (ACOG) and the World Health Organization (WHO).

This study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability of: 1) postpartum remote blood pressure monitoring and 2) NTproBNP testing for postpartum risk stratification in women with HDP at the University of Abuja Teaching Hospital in the Federal Capital Territory of Nigeria

详细描述

Aims:

  1. To evaluate the feasibility, fidelity, and acceptability of home blood pressure monitoring in postpartum patients (n=90) with HDP. The investigators hypothesize that remote blood pressure monitoring will be feasible, implemented as intended, and acceptable among patients, physicians, and other health care workers to improve awareness and early diagnosis of elevated blood pressures (>140/90 mm Hg) in postpartum patients with HDP.
  2. To evaluate the association between N Terminal-proBNP (NT-proBNP) levels and short-term cardiovascular outcomes (i.e., all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality at 12-weeks postpartum) in patients with HDP.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Adults >18 years of age
  • Admitted for delivery
  • Clinical diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia)
  • Control participants:
  • Adults >18 years of age
  • Admitted for delivery
  • with an uncomplicated pregnancy and delivery

排除标准

  • Unable to provide consent
  • Unable to check blood pressure at home

结局指标

主要结局

Rate of recruitment

时间窗: Through study completion at 1 year

Number of participants recruited

次要结局

  • Fidelity(2 weeks)
  • Retention(2 weeks)

研究者

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

Zainab Mahmoud

Instructor of Medicine (Principal Investigator)

Washington University School of Medicine

研究点 (1)

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