Clinical trial NCT02376192: Maternal Microcirculation & SDF Imaging
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Keywords: Microcirculation
Sidestream Dark Field (SDF) Imaging
Spinal Anesthesia
Phenylephrine
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Microvascular Flow Index (MFI)
timeFrame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia
Secondary outcomes:
measure: Microvascular Flow Index (MFI)
timeFrame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia
Other outcomes:
measure: Total Vessel Density (TVD)
timeFrame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia
measure: Perfused Vessel Density (PVD)
timeFrame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia
measure: Proportion of perfused vessels (PPV)
timeFrame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre, Dalhousie University
name: Ronald B George, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2015;60(4):389-95. doi: 10.3233/CH-141851.
citation: Abdo I, George RB, Farrag M, Cerny V, Lehmann C. Microcirculation in pregnancy. Physiol Res. 2014;63(4):395-408. doi: 10.33549/physiolres.932511. Epub 2014 Apr 3.
citation: 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.
citation: 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.