NCT04343235终止4 期
Postpartum Management of Gestational Hypertensive Disorders Using Furosemide: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change of Dose for Antihypertensive Therapy
研究概览
简要总结
- The main purpose of this study is to learn if incorporating a loop diuretic such as furosemide along with labetalol in the routine management of postpartum gestational hypertensive disorders could lower the need for additional anti-hypertensive agents to control blood pressures, improve blood pressures (as measured by systolic blood pressure, diastolic blood pressure and mean arterial blood pressures), shorten hospital stays and decrease readmissions for patients with gestational hypertensive disorders.
- Based on a study by Veena et al1, there is reason to believe that the addition of furosemide to other anti-hypertensives may help decrease the need to add or increase the dose of medication to control blood pressures. There may be potential to shorten hospital stays and decrease readmissions, as well. Collecting data will be done using a prospective, randomized 1:1 controlled study assigning postpartum patients with a gestational hypertensive diagnosis to either labetalol alone or labetalol plus furosemide.
- The study will be performed in the postpartum wing of Miami Valley Hospital Main Campus and would use patients who have consented to participate in the study with enrollees coming from the OB Staff population.
详细描述
Background and Literature Review
- There have been four documented studies investigating loop diuretics in the management of postpartum hypertensive disorders- Matthews et al2, Ascarelli et al3, Amorim et al4, and Veena et al. Of these studies, only Amorim and Veena were able to show statistical significance on any parameters. Amorim was able to show that there was an improvement of SBP, DBP and MAP, but the research was only presented as an abstract at a conference and not published, thereby making it impossible to draw any conclusions or practice guidelines. Veena demonstrated that by using furosemide and nifedipine in combination, the need for additional antihypertensive medication in severe pre-eclampsia in the postpartum period was reduced when compared to nifedipine alone.
- A systematic review5 of postpartum hypertensive disorder management suggested that there was insufficient data to recommend any single pharmacological intervention at this time in the management of gestational hypertensive disorders. The review emphasized the need for further studies to be conducted to help guide management of patients affected by gestational hypertensive disorders in the future.
Objectives
● Main Question
- Does the use of furosemide plus labetalol improve blood pressures in the postpartum period of patients with gestational hypertensive disorders versus labetalol alone?
- Primary
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
- None
盲法说明
randomized open label
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postpartum women delivering at Miami Valley Hospital
- •Diagnosis of gestational hypertension or preeclampsia
- •Able to provide written informed consent
排除标准
- •Diagnosis of chronic hypertension
- •Allergy to study medications
- •Unable to understand English
研究组 & 干预措施
labetalol + furosemide
Experimental
labetalol + furosemide
干预措施: furosemide (Drug)
labetalol + furosemide
Experimental
labetalol + furosemide
干预措施: labetalol (Drug)
labetalol only
Active Comparator
labetalol only
干预措施: labetalol (Drug)
结局指标
主要结局
Change of Dose for Antihypertensive Therapy
时间窗: Change in dose of hypertensive therapy from randomization until hospital discharge (up to 7 days)
number of patients who require a change in the dose of labetalol to control BP
次要结局
- Change of Gestational Hypertensive Disorder Symptoms (Systolic BP)(Average systolic blood pressure for Day 0, Day 1, and Day 2)
- Hospital Readmission(up to 14 days after discharge)
- Hospital Length of Stay(Number of days of hospital stay from randomization to discharge)
- Breastfeeding Status(at 1 week postpartum visit)
- Change of Gestational Hypertensive Disorder Symptoms (Mean Arterial Pressure)(Average mean arterial pressure on Day 0, Day 1, and Day 2)
- Change of Gestational Hypertensive Disorder Symptoms (Diastolic BP)(Average diastolic blood pressure on Day 0, Day 1, and Day 2)
研究者
研究点 (1)
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