Acute Labetalol Use in Preeclampsia Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 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 body-mass index, 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 obesity (BMI>30) on severe hypertension control in patients with 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
- •One sustained severe range blood pressure at Albany Medical Center
排除标准
- •Known allergic reaction to labetlol
- •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 in succession after each severe BP
干预措施: Experimental labetalol dose (Drug)
Current standard of care
Subjects receive 20mg, 40mg 80mg in succession after each severe BP
干预措施: Current standard of care (Other)
结局指标
主要结局
Time to blood pressure control
时间窗: 4 hours after last labetalol dosing
The length of time the subject continued to have non-severe range blood pressure following administration of labetolol.
次要结局
- Maternal adverse events(within 3 months of delivery)
- Neonatal adverse events(within 28 days of delivery)
- Differences in racial response(4 hours after last labetalol dosing)