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
  Purpose

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
Pregnancy
Microcirculation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: An Observational Assessment of the Sublingual Microcirculation of Pregnant and Non-pregnant Women (Parturient Microcirculation - Phase 1)

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 36
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant
Non- Pregnant

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491685

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
IWK Health Centre
  More Information

No publications provided

Responsible Party: Ronald George, Primary Investigator, MD, FRCPC, Assistant professor, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01491685     History of Changes
Other Study ID Numbers: IWK1007223
Study First Received: November 1, 2011
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on April 17, 2014