Parturient Microcirculation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ronald George, IWK Health Centre

ClinicalTrials.gov Identifier:

NCT01491685

First received: November 1, 2011

Last updated: January 18, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 1, 2011
Last Updated Date	January 18, 2012
Start Date ^ICMJE	August 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 18, 2012)	Microvascular Flow Index (MFI) [ Time Frame: 1 yr ] [ Designated as safety issue: No ] The primary outcome is the difference between the MFI of pregnant versus non-pregnant subjects.
Original Primary Outcome Measures ^ICMJE (submitted: December 12, 2011)	MFI [ Time Frame: 1 yr ] [ Designated as safety issue: No ] The primary outcome is the difference between the MFI of pregnant versus non-pregnant subjects.
Change History	Complete list of historical versions of study NCT01491685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 12, 2011)	PVD [ Time Frame: 1 yr ] [ Designated as safety issue: No ] Perfused vessel density PPV [ Time Frame: 1 yr ] [ Designated as safety issue: No ] Proportion of perfused vessels
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Parturient Microcirculation
Official Title ^ICMJE	An Observational Assessment of the Sublingual Microcirculation of Pregnant and Non-pregnant Women (Parturient Microcirculation - Phase 1)
Brief Summary	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.
Detailed Description	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 ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Pregnant group - women with uncomplicated, singleton, at 36 - 40 weeks gestation, non-laboring Non-Pregnant group - healthy nulliparous female volunteers, matched to pregnant patients for age ± 1 year
Condition ^ICMJE	Pregnancy Microcirculation
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Pregnant Non- Pregnant
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	36
Completion Date	October 2011
Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01491685
Other Study ID Numbers ^ICMJE	IWK1007223
Has Data Monitoring Committee	Not Provided
Responsible Party	Ronald George, IWK Health Centre
Study Sponsor ^ICMJE	IWK Health Centre
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	IWK Health Centre
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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