An Observational Assessment of the Sublingual Microcirculation of Pregnant and Non-pregnant Women (Parturient Microcirculation - Phase 1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Microvascular Flow Index (MFI)
研究概览
简要总结
This is an observational study comparing microcirculation of pregnant to non-pregnant women. "Microcirculation" means blood flow to the extremely small blood vessels in one's body. During pregnancy the amount of blood in a woman's body increases. The body responds to this increase by pumping more blood through the heart and narrowing the size of blood vessels.
There are many types of blood vessels that have different roles in the body. Larger blood vessels. Transport blood to and from body organs like the brain and liver. Small vessels (microcirculation)distributes blood to the organ tissues. The microcirculation can change blood flow and blood pressure. Microcirculation is involved in delivering oxygen and nutrients to your body, removing waste products, and regulating body temperature.
The investigators current understanding of the microcirculation in pregnant women is limited. There is a device available that can measure microcirculation. It is known as Sidestream Dark Field (SDF) imaging. It is a special type of camera that captures pictures of the microcirculation. In this study the investigators will compare the microcirculation, as seen with SDF imaging, of pregnant women to non-pregnant women. By improving the investigators understanding of maternal microcirculation the investigators are adding to the knowledge of how the pregnant body works. The investigators hope to then translate this knowledge into further studies to improve maternal and fetal outcomes through prevention and treatment of maternal low blood pressure caused by spinal anesthesia.
详细描述
The objectives of this observational trial are; to compare the sublingual microcirculation of pregnant subjects to that of comparable non-pregnant volunteers; to evaluate the usefulness of a non-invasive technology, SDF imaging in pregnant and non-pregnant subjects.
By improving our understanding of maternal microcirculation we not only add to the knowledge of maternal physiology, we hope to then translate this knowledge into further studies to improve maternal and fetal clinical outcomes through prevention and treatment of maternal hypotension especially in relation to spinal anesthesia.
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
- 是
入选标准
- •American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I Healthy, ASA II - mild and controlled systemic disease)
- •Pregnant: singleton, 36 - 40 weeks EGA, non-labouring
- •Non- Pregnant - Healthy female volunteers who have never been pregnant, matched to pregnant patients for age ± 1 year
排除标准
- •Obesity (BMI > 35 kg/m2)
- •Hypertensive disease (Essential, gestational, or preeclampsia)
- •Diabetes Mellitus Type 1
- •Cardiovascular disease
- •Smoker (1 cigarette or other tobacco product within 12 months)
- •Caffeinated (i.e. coffee, tea, energy drink) beverage with 2 hours
结局指标
主要结局
Microvascular Flow Index (MFI)
时间窗: 1 yr
The primary outcome is the difference between the MFI of pregnant versus non-pregnant subjects.
次要结局
- PVD(1 yr)
- PPV(1 yr)
研究者
Ronald George
Primary Investigator, MD, FRCPC, Assistant professor
IWK Health Centre
