Management of Postpartum Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 2
- 主要终点
- Postpartum Emergency Department visits for hypertensive disorders
研究概览
简要总结
The aim of this study is to assess the effect of a lower treatment threshold for antihypertensive medication and tighter blood pressure control, using remote blood pressure monitoring, on reducing Emergency Room visits for our postpartum patients with hypertensive disease.
详细描述
The aim of this study is to assess the effect of lower treatment threshold for initiating antihypertensive medication and tighter blood pressure control, using remote blood pressure monitoring, on reducing Emergency Room visits for our postpartum patients with hypertensive disease.
The investigators will study and compare two cohorts of patients. The first is a retrospective cohort, including patients delivered at Robert Wood Johnson University Hospital and Cooperman Barnabas Medical Center. The second is a prospective cohort that will enroll patients immediately postpartum who are eligible for our treatment protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Chronic hypertension, gestational hypertension, or preeclampsia.
- •Delivery of a neonate after 20 weeks during their current hospitalization
- •Able to consent
- •18 years old or above
- •English or Spanish speaking
- •Planning to follow up with a physician associated with Robert Wood Johnson University Hospital or Cooperman Barnabas Medical Center
- •Ability to follow directions
排除标准
- •Any medical condition that the providers feel is a contraindication to the MOPP algorithm.
- •Planning to follow up with an outside institution.
- •Unwillingness to take blood pressure at home.
研究组 & 干预措施
Prospective interventional arm
The prospective cohort will identify patients in the postpartum period of their delivery hospitalization who are at risk of readmission for hypertensive disorders in the initial six weeks postpartum. Those at risk include patients with diagnosed with chronic hypertension or PIH. Chronic hypertension is defined as either taking antihypertensive medications or a blood pressure of greater than or equal to 140/90 mm Hg prior to 20 weeks of gestation. Pregnancy induced hypertension includes gestational hypertension, preeclampsia without severe features, preeclampsia with severe features and Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP). The minimum requirement to be diagnosed with this spectrum of disorders is having two blood pressures of greater than or equal to 140/90 mm Hg during the antepartum, intrapartum or postpartum periods.
干预措施: Tight postpartum blood pressure control (Other)
Retrospective observational arm
The retrospective cohort will include all patients diagnosed with chronic hypertension or pregnancy-induced hypertensive (PIH) disorders at Robert Wood Johnson University Hospital and Cooperman Barnabas Medical Center in the past two years, including those presenting to the Emergency Department or readmitted for hypertensive disorders, during the immediate six weeks postpartum.
结局指标
主要结局
Postpartum Emergency Department visits for hypertensive disorders
时间窗: Six weeks from date of delivery
Any patient that returns to the Emergency Department for hypertensive disorders
次要结局
- Postpartum readmissions for hypertensive disorders(6 weeks form date of delivery)
- Number of acute postpartum complications of preeclampsia(6 weeks from date of delivery)
- Lab abnormalities because of preeclampsia(6 weeks from date of delivery)
- Blood pressure at the postpartum visit(6 weeks from date of delivery)
- Breastfeeding rates at 6 weeks postpartum(6 weeks from date of delivery)
- Compliance with follow up at postpartum visits(6 weeks from date of delivery)
- Short-term cardiovascular disease(One year from delivery)
- Socioeconomic factors(One year from delivery)
- Composite maternal cardiovascular and other morbidity(One year from delivery)
研究者
Deepika Sagaram, MD
Assistant Clinical Professor
Rutgers, The State University of New Jersey