Parturient Microcirculation

Pregnancy Clinical Trial

Official title:

An Observational Assessment of the Sublingual Microcirculation of Pregnant and Non-pregnant Women (Parturient Microcirculation - Phase 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491685
• Other study ID #: IWK1007223
• Status: Completed
• Phase: N/A
• First received: November 1, 2011
• Last updated: January 18, 2012
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Microcirculation
• Pregnancy

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular Flow Index (MFI)	The primary outcome is the difference between the MFI of pregnant versus non-pregnant subjects.	1 yr	No
Secondary	PVD	Perfused vessel density	1 yr	No
Secondary	PPV	Proportion of perfused vessels	1 yr	No