Torsemide for the Prevention of Persistent Postpartum Hypertension in Preeclamptic Women: A Randomized, Placebo-Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg
研究概览
简要总结
Currently there is no intervention to prevent persistent postpartum hypertension in preeclamptic women. Physiologically, the use of a pharmacokinetically predictable loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the incidence of persistent postpartum hypertension in preeclamptic women.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postpartum women at ≥ 18 years of age
- •Antepartum/intrapartum or within 24 hours postpartum diagnosis of either:
- •Preeclampsia
- •Preeclampsia with severe features
- •Preeclampsia superimposed to chronic hypertension
排除标准
- •Chronic hypertension without superimposed preeclampsia
- •Gestational hypertension
- •Urine output < 30 cc/h at time of randomization
- •Heart failure or pulmonary edema
- •Hypersensitivity to Torsemide or sulfonylureas
- •Hypokalemia (serum potassium < 3 mEq/L)
- •Preexisting diuretic use within 24 hours prior to randomization
研究组 & 干预措施
Torsemide
Torsemide 20 mg daily for 5 days
干预措施: Torsemide (Drug)
Placebo
Placebo 20 mg daily for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg
时间窗: 0-5 days after delivery
Persistent postpartum hypertension was defined as sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first.
次要结局
- Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)(6 weeks after delivery)
- Change in Lower Extremity Edema(at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery))
- Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)(0-6 weeks after delivery)
- Number of Participants Requiring Postpartum Readmission(0-6 weeks after delivery)
- Length of Hospital Stay After Delivery(0-5 days after delivery)
- Weight Change(at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery))
- Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)(0-5 days after delivery)
- Number of Participants With Side Effects of Therapy - Decreased Breast Milk(0-5 days after delivery)
- Number of Participants With Severe Composite Maternal Morbidity(0-6 weeks after delivery)
研究者
Oscar Andres Viteri Molina
Maternal-Fetal Medicine Fellow
The University of Texas Health Science Center, Houston