Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Readmission
研究概览
简要总结
Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.
详细描述
Enrollment:
Patients will be identified daily using an EMR screening tool. Those that meet inclusion criteria will then be approached by the investigators or research RN for enrollment. Patients consenting to be involved in the study will then be randomly assigned to the nifedipine or labetalol arms of the study. Block randomization will be performed in blocks of 50 with goal of 600 total patients (300 in each arm).
Treatment Protocols
Nifedipine Study Arm:
Patients randomized to Nifedipine will be started on Nifedipine XR 30mg BID. Escalation in therapy to be determined by primary provider. Maximum dose of Nifedipine is 120mg daily. All patients will be monitored for signs and symptoms of hypotension or medication side effect- severe HA, orthostasis, syncope. Patients with further hypertension will then be started on Labetalol as a second agent at 200mg TID and escalated as needed with the goal of being normotensive for at least 12 hours before discharge. Patients will not be kept hospitalized for purposes of the study.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any patient admitted for delivery by cesarean or vaginal delivery at 24 weeks gestation or greater with hypertension(HTN). Hypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart. This definition is consistent with the ACOG definition for pregnancy related HTN. Following enrollment, treatment will be escalated at discretion of primary provider with the goal of normotension.
排除标准
- •History of moderate persistent asthma, coronary artery disease, heart failure, AV heart block, pulmonary edema
- •Contraindication to either Nifedipine or Labetalol
- •HR <60 or >110
- •Native language other than English or Spanish
研究组 & 干预措施
Nifedipine
Patients randomized to Nifedipine will be started on Nifedipine XR 30mg BID. Escalation in therapy to be determined by primary provider. Maximum dose of Nifedipine is 120mg daily. All patients will be monitored for signs and symptoms of hypotension or medication side effect- severe HA, orthostasis, syncope.
干预措施: NIFEdipine ER (Drug)
Labetalol
Patients randomized to Labetalol will be started on 200mg TID. Escalation in therapy to be determined by primary provider. Maximum dose is 2400mg in a day. All patients will be monitored for signs and symptoms of hypotension or medication side effect- orthostasis, syncope, bradycardia.
干预措施: Labetalol Oral Tablet (Drug)
结局指标
主要结局
Readmission
时间窗: 6 months
Patients will be monitored following delivery for readmission to the hospital. To improve patient capture, all patients will be called at 6 months to identify complications or if hospital admission occured in the 6 months following delivery
次要结局
- Medication change or discontinuation(Any time during the 6 months following delivery)
- Medication failure(Any time during the 6 months following delivery)