Oral Nifedipine Versus Intravenous Labetalol for Postpartum (PP) Hypertensive Emergency: a Randomized Clinical Trial (RCT)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Average Time to Initial Blood Pressure Control (minutes)
研究概览
简要总结
The purpose of this study is to assess which blood pressure medication (intravenous labetalol or oral nifedipine) works better in treating severely elevated blood pressure in women who have just delivered a baby.
详细描述
Hypertensive emergencies cause significant maternal morbidity and mortality in the postpartum period. In order to reduced these risks, the recommendation is to treat women with severe range blood pressure with either intravenous labetalol or oral nifedipine; it is unclear which medication is superior. The objective of this study is to prospectively enroll women who have hypertensive emergencies in the postpartum period; women will be randomized in a 1:1 fashion and treated with one of the two antihypertensives to see which one works better.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intravenous labetalol
Intravenous Labetalol: Patients randomized to IV labetalol will receive 20mg initially, followed by escalating doses of 40mg, 80mg, 80mg, then 80mg every 20 minutes until the therapeutic goal is achieved, for a maximum of 5 doses. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
干预措施: Labetalol (Drug)
Oral Nifedipine
Oral nifedipine: Once diagnosis of hypertensive emergency is confirmed on repeat blood pressure, patients randomized to oral nifedipine will receive 10mg initially, with repeated doses of 20mg every 20min, for up to a maximum of 5 doses or until the therapeutic blood pressure goal of <160 systolic and <105 diastolic is achieved. If the therapeutic goal is not achieved after 5 doses, crossover to the alternative study medication will occur.
干预措施: Nifedipine (Drug)
结局指标
主要结局
Average Time to Initial Blood Pressure Control (minutes)
时间窗: Up to 48 hours
The primary outcome will be time (minutes) interval required to achieve the therapeutic BP goal of \<160 mmHg systolic and \<110 mmHg diastolic.
次要结局
- Average Number of Recurrence of Severe Blood Pressure(Up to 48 hours)
- Total Number of Participants Who Need for Second Antihypertensive Agent(Up to 48 hours)
研究者
Whitney Booker
Assistant Professor of Obstetrics and Gynecology
Columbia University