Furosemide for Prevention of Severe Postpartum Hypertension: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Composite maternal morbidity
研究概览
简要总结
The purpose of this study is to determine whether postpartum administration of furosemide to women with antepartum hypertensive disorders (gestational hypertension, preeclampsia) or elevated blood pressure in the first 24 hours following delivery reduces severe postpartum hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women > 18 years of age or emancipated minors
- •Women undergoing vaginal or cesarean delivery at > 23 weeks gestation with:
- •Antepartum diagnosis of gestational hypertension
- •Antepartum diagnosis of preeclampsia
- •Antepartum diagnosis of preeclampsia with severe features
- •Mild hypertension (<150/100) in first 24 hours following delivery
排除标准
- •Chronic hypertension
- •Allergy to furosemide
- •Pre-existing hypokalemia (serum K < 3.0 meq/L)
- •Chronic kidney disease
- •Serum Cr > 1.1
- •Inability to obtain informed consent
- •Pre-existing diuretic use
研究组 & 干预措施
Furosemide/Potassium chloride
40 mg furosemide; 20 meq potassium chloride
干预措施: Furosemide (Drug)
Furosemide/Potassium chloride
40 mg furosemide; 20 meq potassium chloride
干预措施: Potassium chloride (Drug)
Placebo
Placebo #1, Placebo #2
干预措施: Placebo #1 (Drug)
Placebo
Placebo #1, Placebo #2
干预措施: Placebo #2 (Drug)
结局指标
主要结局
Composite maternal morbidity
时间窗: 0-6 weeks following delivery
Requiring antihypertensive medication at discharge, readmission for blood pressure, end-organ damage from hypertension
次要结局
- Adverse events associated with furosemide(0-6 weeks following delivery)
研究者
David Haas
Professor of Obstetrics and Gynecology
Indiana University