Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized Controlled Noninferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Length of Stay
研究概览
简要总结
A significant number of pregnancies are complicated by hypertensive disorders. Hypertension often worsens in the postpartum period and many women need started on medications. Currently, recommended medications for blood pressure management in pregnant and postpartum women are limited, with labetalol and nifedipine ER being the most commonly used medications. While these medications are both effective, they are not without limitations. Amlodipine is a medication in the same class as nifedipine ER. It is a first-line antihypertensive in the general population. It tends to have less side effects than nifedipine ER. It has not been studied specifically in postpartum women. The purpose of this study is to determine if amlodipine is noninferior to nifedipine ER in managing hypertension 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
- 否
入选标准
- •Postpartum women with a diagnosis of chronic hypertension, gestational hypertension, or preeclampsia
- •Delivery at or beyond 20 weeks' gestation
- •Need for antihypertensive therapy, defined as blood pressure >/= 150 mmHg systolic and/or 100 mmHg diastolic on two occasions four hours apart or isolated blood pressure >160/110 mmHg
- •English or Spanish-speaking
- •Age 18 years or older
排除标准
- •Use of antihypertensive prior to delivery (for any indication)
- •Allergy to nifedipine ER or amlodipine
- •Persistent tachycardia (as defined by the treatment team)
研究组 & 干预措施
Amlodipine
干预措施: Amlodipine (Drug)
Nifedipine ER
干预措施: NIFEdipine ER (Drug)
结局指标
主要结局
Length of Stay
时间窗: Through hospital stay, on average 2-5 days
length of stay from delivery until discharge
次要结局
- Number of Acute Treatments After Medication Initiation(Through hospital stay, on average 2-5 days)
- Patient Reported Side Effects(Through hospital stay, on average 2-5 days)
- Number of Patients Discontinuing Medication Due to Side Effects(Through hospital stay, on average 2-5 days)
- Number of Patients Requiring Hospital Readmission(until 6 weeks postpartum)
- Breastfeeding Duration of 6+ Weeks(until 6 weeks postpartum)
- Number of Patients Reporting Satisfaction With Breastfeeding Experience on Patient-completed Questionnaire(until 6 weeks postpartum)