Pilot Treatment of Persistent Non-Severe Postpartum Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Average Systolic Blood Pressure at 1 Week Postpartum
研究概览
简要总结
This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. There are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.
详细描述
Study groups will include a treatment with nifedipine extended release or no treatment. Subjects will be randomized 1:1. Subjects randomized to the treatment group will be provided the study drug (nifedipine extended release) at an initial dose of 30mg daily in 1-month supply. The control group will not receive any drug for blood pressure control. the primary outcome is systolic blood pressure at 1 week postpartum.
Subjects in both groups will be scheduled for a 1-week postpartum blood pressure check and routine 4 week postpartum visit. Medication compliance in the treatment group will be assessed via validated questionnaire. The primary outcome of this study is average systolic blood pressure at 1 week postpartum. Patients will be given instructions on blood pressure ranges and specific symptoms when they should contact study staff.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Antepartum diagnosis of gestational hypertension
- •preeclampsia
- •superimposed preeclampsia without antepartum chronic hypertension medication
- •Delivery at 23 weeks or greater
- •Persistent elevation in BP >24 hours postpartum (>140/90 mm Hg) (2 or more BP >4 hours apart)
- •18 years or older
- •English speaking
排除标准
- •Need for continuation of antepartum antihypertensive medication
- •Contraindication of calcium channel blocker use
- •Severe range (160/110 mm Hg) blood pressure requiring treatment >24 hours after delivery
- •Requires a 2nd oral antihypertensive medication for blood pressure control inpatient
- •Acute cardiomyopathy or heart failure
- •Creatinine ≥1.5
- •Blood pressure <90/60 within 24 hours of discharge
研究组 & 干预措施
Treatment Group
The treatment group will be provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal.
干预措施: Nifedipine Extended-Release Tablets (Drug)
结局指标
主要结局
Average Systolic Blood Pressure at 1 Week Postpartum
时间窗: 1 week postpartum
次要结局
- Method of Feeding(up to 4 weeks postpartum)
- Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum(4 weeks postpartum)
- Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum(1 week postpartum)
- Average Diastolic Blood Pressure at 4 Weeks Postpartum(4 weeks postpartum)
- Number of Participants With ED/Triage Visits(up to 4 weeks postpartum)
- Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum(1 week postpartum)
- Number of Participants With Hospital Readmission(up to 4 weeks postpartum)
- Average Diastolic Blood Pressure at 1 Week Postpartum(1 week postpartum)
- Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum(1 week postpartum)
- Average Systolic Blood Pressure at 4 Weeks Postpartum(4 weeks postpartum)
- Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum(1 week postpartum)