Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cardiac output measured by transthoracic echocardiography (TTE) at rest: CO mL/min.
研究概览
简要总结
The goal of this observational trial is to determine the resting cardiac output (CO) using transthoracic echocardiography (TTE) in a cohort of people with untreated preeclampsia, and a cohort of healthy normotensive pregnant people.
详细描述
This study seeks to evaluate cardiac output in people with untreated preeclampsia in a tertiary referral centre in the US. In doing so the investigators hope to better understand the underpinning of the pathophysiology of this condition and provide evidence for (or against) the new theory of the development of preeclampsia. The investigators also seek to examine CO changes at birth during cesarean delivery (CD) comparing healthy pregnant people with people with preeclampsia and further understand the changes in cardiac output (CO) after treatment with antihypertensive agents for preeclamptic patients so that the investigators may better rationale treatment with these agents and evaluate the changes that may occur at the time of CD and after cesarean birth in people with preeclampsia using TTE so that fluid therapy and blood pressure treatment can be prescribed based on hemodynamic findings. Further the investigators aim to imbed echocardiography into the management of people with preeclampsia and to determine the feasibility and long-term sustainability of conducting echocardiography studies in pregnant people with a multidisciplinary group at the Brigham and Women's Hospital Boston.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Preeclampsia Participant.
- •Preclampsia definition: People with preeclampsia will be recruited at the time of diagnosis or suspected diagnosis of preeclampsia, according to accepted definitions of preeclampsia. Preeclampsia with severe features will be defined using the American College of Obstetrics and Gynecology definition.
- •Nulliparous, singleton pregnancy,
- •≥20 weeks gestation
- •without any preexisting cardiovascular, hepatic, or respiratory problems,
- •No preexisting uterine abnormality including benign tumors, or placental adhesive disorder,
- •Not in labor,
- •Not with prior to treatment for preeclampsia,
- •Body mass index ≤ 40 kg/m2, age 18 to 50 years.
- •Healthy Participant:
- •Healthy pregnant people will be defined as
- •American Society of Anesthesiologists (ASA) Classification II with no significant medical or surgical illness,
- •Nulliparous (first pregnancy beyond 20 week's gestation)
- •Non-smokers, singleton pregnancy
- •Not having ruptured membranes
- •No uterine abnormalities
- •No placentation abnormalities.
- •Not receiving any vasoactive medication including salbutamol
- •Not on thyroid replacement hormones
排除标准
- •Preeclampsia Participant:
- •Multiparous, multiple pregnancy,
- •Previous cardiovascular, hepatic or respiratory problems
- •Gestational diabetes,
- •Hemodynamic or neurologically unstable patient
- •Unable to tolerate a 30-minute ultrasound examination (TTE)
- •Age less than 18 or greater than 50 years
- •BMI > 40 kg/m2,
- •Gestation < 20 weeks.
- •Healthy Participant:
- •Current administration of vasoactive drugs including salbutamol
- •Current administration of thyroxine
- •Pre-existing or gestational diabetes
- •Tobacco use
- •Pre-existing or gestational hypertension or preeclampsia
- •Known uterine abnormality, in labor or ruptured membranes
- •Unable to tolerate a 30-minute ultrasound examination (TTE)
- •Age less than 18 or greater than 50 years
- •BMI > 40 kg/m2,
- •Gestation < 20 weeks.
结局指标
主要结局
Cardiac output measured by transthoracic echocardiography (TTE) at rest: CO mL/min.
时间窗: During gestation (8 wks to 42 wks, during clinic or hospital visits) with diagnosis of Preeclampsia
Cardiac output measured by transthoracic echocardiography (TTE)
次要结局
- cardiac output measured by transthoracic echocardiography (TTE) after treatment with antihypertensive agents, and during CD and postpartum(Post-treatment with antihypertensive (<60 min; during clinic or hospital ), Postpartum (cesarean or vaginal delivery; <60 min; immediately after to up to 6 hrs after delivery))
研究者
Michaela Kristina Farber, MD
Associate Professor, Harvard Medical School
Brigham and Women's Hospital