Furosemide for Accelerated Recovery of Blood Pressure Postpartum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Time to Resolution
研究概览
简要总结
A randomized, double-blind, placebo-controlled single center investigation of furosemide's effect on postpartum blood pressure control in pregnancies affected by hypertensive disorders of pregnancy
详细描述
Hypertensive disorders of pregnancy are recognized causes of significant maternal/fetal morbidity and mortality, accounting for approximately 18% of maternal deaths worldwide. While significant research has been done on the evaluation and management of hypertension during pregnancy, studies of postpartum hypertension (PPHTN) are usually limited by their retrospective design and focus on inpatients in the immediate postpartum period (2-6 days), or patients who were readmitted due to complications related to hypertension. Few studies have investigated the incidence and proper management of hypertension in the postpartum period. Furthermore, in the United Kingdom, a review of maternal deaths determined that 10% were related to hypertensive disorders in pregnancy (HDP) in the postpartum period. Postpartum hypertension is also the cause of approximately 27% of readmissions to the hospital. These studies clearly show that PPHTN is associated with significant morbidity and that it is important to develop interventions that can reduce its effects.
In patients with HDP, postpartum blood pressure has been shown to decrease in the first 48 hours postpartum only to then increase in days 3-6 postpartum. This phenomenon is thought to be secondary to large fluid shifts, both secondary from fluid retention during the pregnant state as well as from fluids given intrapartum. Furthermore, large volumes of sodium are also mobilized into the intravascular compartment at this time. Given the latter, furosemide, a loop diuretic that mobilizes sodium and fluid excretion has been posed as a method to prevent severe range blood pressures and their associated maternal morbidity in the postpartum period.
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)
盲法说明
Study medication (furosemide) and placebo will be stored at room temperature at the University of Pennsylvania research pharmacy. Pharmacy will be responsible for labeling and randomizing the medications.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hypertensive disorder of pregnancy diagnosed antepartum or intrapartum
- •Gestational hypertension
- •Pre-eclampsia with or without severe features
- •Superimposed pre-eclampsia with or without severe features
- •New diagnosis of HDP within 24 hours from delivery
- •Postpartum, delivery ≥ 20 weeks estimated gestational age
- •Age ≥18 years old
排除标准
- •History of allergic reaction to furosemide
- •High risk comorbidities for which treatment may be indicated or contraindicated: class C or higher diabetes mellitus, chronic kidney disease or baseline creatinine >1.2, cardiac disorders including cardiomyopathy, congenital heart disease, angina or coronary heart disease, rheumatic disease (lupus), sickle cell disease
- •Baseline labs with K <3
- •Use of furosemide or other diuretics antepartum or intrapartum
- •Use of ototoxic agents including aminoglycosides (ie, Gentamicin for >1 dose), cephalosporins (ie Ancef >1 dose),
- •Patient unstable for protocol per investigator's judgement
研究组 & 干预措施
Oral furosemide
Oral furosemide 20 mg/day for a total of 5 consecutive doses.
干预措施: Oral furosemide (Drug)
Placebo Oral Tablet
Placebo once per day for a total of 5 consecutive doses.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Time to Resolution
时间窗: 0-14 days postpartum
To compare the time (days) required to achieve a resolution of elevated blood pressure, adjusted for mode of delivery.
Persistently Elevated Blood Pressures 7 Days Postpartum
时间窗: 0-7 days postpartum
To compare the rate of persistently elevated blood pressures (\>140/90) in women that receive a five day furosemide course compared to those that receive placebo.
次要结局
- Number of Subjects Experiencing One or More Adverse Effects(0-6 weeks postpartum)
- Number of Subjects Who Had Severe Hypertension Postpartum(0-6 weeks postpartum)
- Postpartum Length of Stay(0-6 weeks postpartum)
- Subjects With Complications During Hospitalization(0-6 weeks postpartum)
- Number of Subjects That Required for Additional Antihypertensives(0 to 6 weeks post-partum)
- Postpartum Readmission(0-6 weeks postpartum)
研究者
Lisa Levine
Assistant Professor
University of Pennsylvania