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临床试验/NCT04755764
NCT04755764招募中不适用

The Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by Impedance Cardiography in Early Pregnancy

Marshall University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Cardiac output

研究概览

简要总结

The purpose of the research is to characterize the effect of labetalol, atenolol, and nifedipine on maternal hemodynamics early in pregnancy. Patients will be given medication based on their hemodynamics and asked to return for a repeat measurement.

详细描述

When a patient presents to the Maternal Hypertension Center at Cabell Huntington Hospital, she will receive a non-invasive hemodynamic assessment via the NICaS system as per usual protocol. The NICaS system uses impedance cardiography which provides a reliable assessment of cardiovascular, respiratory, and fluid parameters. In typical practice, the vasodilator nifedipine is initiated for increased systemic vascular resistance and elevated cardiac output is treated with beta blockade (via either atenolol or labetalol). The medication to be given to each subject will be based on their hemodynamics. Specifically, nifedipine will be given for a mean arterial pressure >100 and a beta blocker will be given for a cardiac output >8 l/min. The patients will be asked to return in one week for repeat ICG measurement.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients presenting to Maternal Hypertension Center at Cabell Huntington Hospital
  • English speaking
  • 18-45 years old.
  • Willing to provide informed consent
  • Gestational age prior to 15 weeks gestation

排除标准

  • Non-English speaking patients, patients
  • <18 years old or >45 years old
  • Not willing or able to provide consent
  • Gestational age >15 weeks

研究组 & 干预措施

Beta blockade

Beta blocker (labetalol or atenolol) will be given for a cardiac output >8 l/min.

干预措施: Labetalol (Drug)

Beta blockade

Beta blocker (labetalol or atenolol) will be given for a cardiac output >8 l/min.

干预措施: Atenolol (Drug)

Nifedipine

Nifedipine will be given for a mean arterial pressure >100.

干预措施: Nifedipine (Drug)

结局指标

主要结局

Cardiac output

时间窗: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

Measured in liters per minute

Systemic vascular resistance

时间窗: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

Measured by dynes · sec/cm\^-5

Heart rate

时间窗: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

Measured in beats per minute

Systolic blood pressure

时间窗: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

Measured in mmHg

Diastolic blood pressure

时间窗: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

Measured in mmHg

Mean arterial pressure

时间窗: Initial assessment of hemodynamic parameters will be measured. A change from baseline will be assessed one week later.

Measured in mmHg

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

Jesse Cottrell

Assistant Professor

Marshall University

研究点 (1)

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