Maternal Microcirculation & SDF Imaging
Information source: IWK Health Centre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy
Intervention: Initial MicroScan® (Microvision Medical) SDF Measurement (Device); Spinal Anesthesia- Bupivacaine (Drug); Comparative MicroScan® (Microvision Medical) SDF Measurement (Device); Bolus Phenylephrine/Ephedrine Treatment (Drug); Phenylephrine Infusion (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: IWK Health Centre Official(s) and/or principal investigator(s):
Ronald B George, MD FRCPC, Principal Investigator, Affiliation: IWK Health Centre, Dalhousie University
Summary
This is a study of pregnant women undergoing a cesarean delivery. It will compare their
microcirculation before and after the anesthetic. Microcirculation means blood flow to the
extremely small blood vessels in the body. It will also look at the differences in
microcirculation of participants who receive an infusion of phenylephrine compared to
participants who don't. The investigators hypothesize that spinal anesthesia will reduce the
vascular density and proportion of perfused vessels.
Clinical Details
Official title: Maternal Microcirculation & SDF Imaging: A Novel Assessment of the Microcirculation During Cesarean Delivery With Spinal Anesthesia and the Impact of Phenylephrine Prophylaxis to Prevent Spinal Anesthesia-induced Hypotension.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Microvascular Flow Index (MFI)
Secondary outcome: Microvascular Flow Index (MFI)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I - Healthy,
ASA II - mild and controlled systemic disease)
- Singleton pregnancies
- 36-42 weeks gestation
- Non-labouring
- Scheduled cesarean delivery
- English speaking
- Age 18-45 years
Exclusion Criteria:
- Cardiovascular disease
- Hypertensive disease of pregnancy (i. e. mild & severe preeclampsia)
- Allergy to phenylephrine, or any other standardized medication
- Obesity (BMI > 35 kg/m2)
- Diabetes Mellitus type 1
- Smoker
- Coffee/Caffeine intake within 6 hours of SDF measurement
Locations and Contacts
IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada
Additional Information
Related publications: George RB, DesRoches J, Abdo I, Lehmann C. Maternal microcirculation and sidestream dark field imaging: A prospective assessment of the association between labour pain and analgesia on the microcirculation of pregnant women. Clin Hemorheol Microcirc. 2014 Jun 16. [Epub ahead of print] Abdo I, George RB, Farrag M, Cerny V, Lehmann C. Microcirculation in pregnancy. Physiol Res. 2014 Sep 4;63(4):395-408. Epub 2014 Apr 3. Review. George RB, Munro A, Abdo I, McKeen DM, Lehmann C. An observational assessment of the sublingual microcirculation of pregnant and non-pregnant women. Int J Obstet Anesth. 2014 Feb;23(1):23-8. doi: 10.1016/j.ijoa.2013.08.013. Epub 2013 Sep 8. Lehmann Ch, Abdo I, Kern H, Maddison L, Pavlovic D, Sharawi N, Starkopf J, Hall R, Johnson P, Williams L, Cerny V; MiDAS (Microcirculation Diagnostics and Applied Studies) group. Clinical evaluation of the intestinal microcirculation using sidestream dark field imaging--recommendations of a round table meeting. Clin Hemorheol Microcirc. 2014;57(2):137-46. doi: 10.3233/CH-141810.
Starting date: January 2014
Last updated: February 25, 2015
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