Treatment of Severe Hypertension With Impendence Cardiography (ICG) Directed Therapy; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The systolic blood pressure
研究概览
简要总结
The purpose of the study is to compare the usefulness of Impedence Cardiography (ICG) directed therapy in treating severe range hypertension in pregnant women at term.
详细描述
Research Protocol
Study Design: Randomized Control Trial This is a randomized control trial comparing the usefulness of impedance cardiography (ICG) directed therapy in treating severe range hypertension (systolic BP >160 OR diastolic BP >110) in patients greater than 20 weeks gestation. All patients in the study will receive standard of care medication within the suggested timeframe by the American College of Obstetrics and Gynecology (ACOG). All patients will receive a hemodynamic assessment prior to receiving and after receiving medications. The treatment patients will receive either labetalol or nifedipine therapy for hypertension based on their hemodynamic parameters. The control group will receive medication based on provider preference (which is the usual plan of care).
Study Population:
Patients presenting to Labor and Delivery at Cabell Huntington Hospital being treated for severe range blood pressures. Consent will be obtained prior to randomization to standard care or ICG directed care. Patient age range will be from age 15 to approximately 45.
Schedule of Assessment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients presenting to Labor and Delivery at Cabell Huntington Hospital being treated for severe range blood pressure after 20 weeks gestation. Patients will be English speaking and range in ages from 15-45 years old. Patient's will be consented prior to randomization.
排除标准
- •Patients presenting to Labor and Delivery at Cabell Huntington Hospital with normal range blood pressures, or those with elevated blood pressures who do not consent to the study, patients <20 weeks gestation, or patients with eclampsia.
结局指标
主要结局
The systolic blood pressure
时间窗: 1 year
mmHg
The diastolic blood pressure
时间窗: 1 year
mmHg
heart rate
时间窗: 1 year
beats/minute
cardiac output (L/min)
时间窗: 1 year
liters per minute
mean arterial pressure
时间窗: 1 year
mmHg
systemic vascular resistance
时间窗: 1 year
dynes · sec/cm\^-5
次要结局
未报告次要终点
研究者
Jesse Cottrell
Assistant Professor
Marshall University