Acute Control of Chronic Hypertension in Preeclampsia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Time to blood pressure control
研究概览
简要总结
The purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's history of preexisting hypertension, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.
详细描述
The investigators seek to asses the effect of preexisting hypertension on the patient's response to treatment for severe hypertension in preeclampsia with severe features. The investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the American College of Obstetricians and Gynecologists in 2015.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The principle investigator and outcomes assessor are masked to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Gestational age ≥ 24 weeks
- •Singleton gestation
- •Chronic hypertension as defined as two elevated blood pressures (SBP ≥ 140mmHg and/or DBP ≥ 90mmHg) at least 4 hours apart before 20 weeks gestation
排除标准
- •Known allergic reaction to labetalol
- •Persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month)
- •Obstructive airway disease
- •Bradycardia < 70 beats/min
- •Heart block > 1st degree or history of heart failure
研究组 & 干预措施
Experimental labetalol dose
Subjects receive 40mg, 60mg, 80mg after each severe BP
干预措施: Experimental dosing of labetalol (Drug)
Current standard of care
Subjects receive 20mg, 40mg, 60mg after each severe BP
干预措施: Standard dosing of labetalol (Other)
结局指标
主要结局
Time to blood pressure control
时间窗: This outcome will be measured during antepartum admission and will start with the first dose of IV labetalol given for severe blood pressure until subsequent blood pressure check is non-severe (<160 systolic and <110 diastolic), ending with delivery
length of time in minutes between IV labetalol treatment and non-severe blood pressure
Length of blood pressure control
时间窗: This outcome will be measured during antepartum admission and will start with the first non-severe blood pressure after IV labetalol dosing until the next dose of IV labetalol is indicated (by severe blood pressure), ending with delivery
length of time in minutes between successful treatment resulting in non-severe blood pressure and need for next dose of IV labetalol
次要结局
- Maternal adverse events(within 3 months of delivery)
- Neonatal adverse events(within 28 days of delivery)