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Maternal Microcirculation & SDF Imaging

NCT02376192 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-03-03

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

DEVICE

Initial MicroScan® (Microvision Medical) SDF Measurement

Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.

DRUG

Spinal Anesthesia- Bupivacaine

The spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine.

DEVICE

Comparative MicroScan® (Microvision Medical) SDF Measurement

A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.

DRUG

Bolus Phenylephrine/Ephedrine Treatment

Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.

DRUG

Phenylephrine Infusion

Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.

Sponsors & Collaborators

  • IWK Health Centre

    lead OTHER

Principal Investigators

  • Ronald B George, MD FRCPC · IWK Health Centre, Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376192 on ClinicalTrials.gov