|ClinicalTrials.gov Identifier: NCT01491685|
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : January 19, 2012
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Observational Model:||Case Control|
|Official Title:||An Observational Assessment of the Sublingual Microcirculation of Pregnant and Non-pregnant Women (Parturient Microcirculation - Phase 1)|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
- Microvascular Flow Index (MFI) [ Time Frame: 1 yr ]The primary outcome is the difference between the MFI of pregnant versus non-pregnant subjects.
- PVD [ Time Frame: 1 yr ]Perfused vessel density
- PPV [ Time Frame: 1 yr ]Proportion of perfused vessels
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491685
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada|