A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Prolonged Hospitalization
研究概览
简要总结
This study evaluates whether nifedipine or enalapril is better at decreasing the amount of medical resources used in the postpartum period by women who have high blood pressure in pregnancy and the postpartum period. Half of participants will receive enalapril while the other half will receive enalapril. We will compare the two groups in the amount of medical resources used which we are defining as prolonged hospitalizations, unscheduled medical visits and/or hospital readmissions in the postpartum period.
详细描述
This is randomized controlled trial to investigate if enalapril is superior to nifedipine in terms of medical resources used in postpartum women with hypertension. These are both antihypertensives we commonly use in the postpartum period for women with hypertension in pregnancy but we do not know which medication works better at decreasing prolonged hospitalizations, the number of unscheduled medical visits and/or readmissions to the hospital.
Nifedipine is more traditionally used and well-validated by current medical literature. However, enalapril's mechanism of action is better suited to the dysregulation of blood pressure that can occur with hypertensive disorders of pregnancy. Therefore, we hypothesize that enalapril is superior to nifedipine in terms of medical resources used 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
- 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
- 是
入选标准
- •diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic hypertension
- •provider wanting to initiate antihypertensive in the postpartum period
- •the patient is not currently on >1 antihypertensive
- •plans to receive postpartum care at the hospital or affiliated clinic
排除标准
- •sustained pulse <60 or >120 BPM over four hours
- •allergy to any of the antihypertensives
- •creatinine greater than or equal to 1.5
- •strict contraindication to any of the antihypertensives
- •history of failed treatment with any of the antihypertensives
研究组 & 干预措施
Nifedipine
This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive.
干预措施: NIFEdipine ER (Drug)
Enalapril
This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive.
干预措施: Enalapril (Drug)
结局指标
主要结局
Prolonged Hospitalization
时间窗: up to six weeks postpartum
Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
Visit to Labor and Delivery Triage for Evaluation
时间窗: up to six weeks postpartum
Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason
Postpartum Readmission
时间窗: up to six weeks postpartum
Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period
Unscheduled Clinic Appointment
时间窗: up to six weeks postpartum
Participants who have any additional clinic appointments for any clinical reason in the postpartum period beyond the two appointments (around 1 week and 6 weeks postpartum) that are routinely scheduled
次要结局
- Time to Blood Pressure Control(up to six weeks postpartum)
- Number of Participants Who Needed for Additional Antihypertensives(up to six weeks postpartum)
- Time to Discharge(up to six weeks postpartum)
- Clinically Significant Hypotension or Hypertension(up to six weeks postpartum)
- Creatinine Values at 1-2 Weeks After Discharge(1-2 weeks)
- Continued Need for Antihypertensive(up to six weeks postpartum)
- Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received(up to six weeks postpartum)
- Patient Self-reported Compliance With Their Antihypertensive Regimen(up to six weeks postpartum)
- Creatinine Level Around 6 Weeks After Delivery(6 weeks after delivery)
研究者
Thomas Frederick McElrath, M.D.,Ph.D.
Principal Investigator
Brigham and Women's Hospital