Microcirculatory and Tissue and Cerebral Oxygenation Differences Between Preeclampsia and Normal Pregnancy: An Observation Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Assessment of microcirculatory changes by sidestream darkfield microscopy (SDF)
研究概览
简要总结
Preeclampsia is a disease of pregnancy affecting 3% to 8% of all pregnancies and is a major cause of maternal and perinatal morbidity and mortality. Characterized by alter placentation with subsequent release of inflammatory mediators leading to a generalized endothelial dysfunction. It is now accepted that endothelial dysfunction heralds the clinical manifestations of preeclampsia.
The side-stream darkfield (SDF) microscopy device emits a 550 nm green light with a depth region of interest of 500 um. Green light is absorbed by the erythrocytes and appears black. SDF is a well-known non-invasive tool that can study the microcirculatory changes. It was used before in many situations especially in sepsis and septic shock patients.
Near-infra-red spectroscopy (NIRS) device, measures the absorbance of near-infra-red (NIR) light by tissues perfused with oxygenated blood, and is capable of measuring changes in parenchymal volume tissues. It was used before in many situations (including pregnant patients) to reflect the tissue oxygenations.
The investigators are planning to use the SDF and NIRS tools to study the microcirculatory change in preeclamptic subjects and normal pregnant subjects. If these two devices are able to determine any changes this should stand as a baseline for future studies in this field.
详细描述
Study procedures:
- Consented at the time of enrollment in the study, which will be at hospital admission for delivery.
- Demographic data, medical history, obstetrical history, prenatal history and delivery information will be obtained from medical records and the subject
- Proteinuria, Placental weight, BMI, Birth weight and gender, mother smoker or not, clinical parameter of preeclampsia, and severity of preeclampsia, uterine artery Doppler results will be collected from medical records .
- SDF and NIRS application will be done once.
Measurements:
Sidestream dark field (SDF)
The side-stream darkfield camera ( CytoCam) will be put under the subjects tongue for 5-10 minutes. Multiple pictures of the small blood vessels will be taken.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years and older females (10 with diagnosis of preeclampsia and 10 with normal pregnancy),
- •planned to deliver at UVA
排除标准
- •patients with:
- •diabetes,
- •gestational diabetes,
- •gestational hypertension,
- •chronic hypertension,
- •chorioamniotitis
结局指标
主要结局
Assessment of microcirculatory changes by sidestream darkfield microscopy (SDF)
时间窗: Day 1
To assess whether sidestream darkfield microscopy (SDF) and could detect microcirculatory changes in patients who developed preeclampsia versus those who do not.
Tissue oxygenation assessed using Near-infra-red spectroscopy (NIRS)
时间窗: Day 1
Near-infra-red spectroscopy (NIRS),
次要结局
未报告次要终点
研究者
Mohamed Tiouririne, MD
Associate Professor, Anesthesiology
University of Virginia
