An Observational Study of Perinatal Outcomes Following Change in Clinical Criteria in for Treatment of Maternal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,003
- 试验地点
- 1
- 主要终点
- Number of patients with Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine > 1.5mg/dL), and/or or Myocardial Ischemia.
研究概览
简要总结
The purpose of this study is observe outcomes before and after a change in clinical practice in the threshold for management of severe hypertension in pregnancy and the post-partum period. Outcomes will be observed for 10 months under the current (traditional) clinical blood pressure threshold for acute treatment of hypertension, which is >= 160 millimeters of mercury (mmHg) systolic blood pressure (SBP). This will be followed by one month of education about rationale for the new SBP threshold of >= 180 mmHg and change of clinical guidelines. Then, there will be 10 months of observation after adopting the updated clinical threshold for acute antihypertensive treatment (>= 180 SBP).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •any individual > 20 weeks' gestation in triage or admitted at Children's Memorial Hermann Hospital (CMHH) and with blood pressure with >= 160/110 mmHg
排除标准
- •Active seizure, stroke, Congestive Heart Failure (CHF)/pulmonary edema, acute kidney injury (AKI), or myocardial infarction (MI)
- •A history of stroke, CHF, chronic kidney disease (CKD), MI
- •Have Hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome or thrombocytopenia (platelets < 100×10^9/L)
- •Persistent neurologic symptoms including headache >8/10 one hour after analgesic or blurry vision/loss of vision
结局指标
主要结局
Number of patients with Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine > 1.5mg/dL), and/or or Myocardial Ischemia.
时间窗: during the time of delivery hospitalization (about 2 days to 3 months)
The primary outcome is a composite outcome, and will be reported as number of patients who have Congestive Heart Failure/Pulmonary Edema, hemorrhagic or ischemic Stroke, Acute Kidney Injury (creatinine \> 1.5mg/dL), and/or Myocardial Ischemia.
次要结局
- Number of patients with posterior reversible encephalopathy syndrome (PRES)(during the time of delivery hospitalization (about 2 days to 3 months))
- Number of patients with hemolysis, elevated liver enzymes, low platelets (HELLP) syndrome(during the time of delivery hospitalization (about 2 days to 3 months))
- Number of patients with non-reassuring fetal heart rate tracing (NR-FHRT) requiring caesarean delivery(at the time of delivery)
- Number of patients with Apgar score < 7 at 5 min(5 minutes after birth)
- Number of patients with placental abruption(during the time of delivery hospitalization (about 2 days to 3 months))
- Number of patients with eclampsia(during the time of delivery hospitalization (about 2 days to 3 months))
研究者
Kristen Cagino
Fellow
The University of Texas Health Science Center, Houston