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Completed

NCT Number: NCT02376192

Maternal Microcirculation & SDF Imaging

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.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Initial MicroScan® (Microvision Medical) SDF Measurement

Device

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

Spinal Anesthesia- Bupivacaine

Drug

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.

Comparative MicroScan® (Microvision Medical) SDF Measurement

Device

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

Bolus Phenylephrine/Ephedrine Treatment

Drug

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

Phenylephrine infusion

Drug

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

Primary outcomes

  1. Microvascular Flow Index (MFI)

    Time frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia

    The change in MFI of participants; measured immediately prior to, and within 10 minutes following the induction of spinal anesthesia

Secondary outcomes

  1. Microvascular Flow Index (MFI)

    Time frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia

    The difference between the MFI measured within 10 minutes following the induction of spinal anesthesia in participants who receive phenylephrine via a continuous infusion for the prevention of spinal anesthesia-induced hypotension compared to those who may receive phenylephrine boluses for treatment of spinal anesthesia-induced hypotension.

Other outcomes

  1. Total Vessel Density (TVD)

    Time frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia

  2. Perfused Vessel Density (PVD)

    Time frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia

  3. Proportion of perfused vessels (PPV)

    Time frame: Immediately prior to, and within 10 minutes of induction of spinal anesthesia

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 3, 2015
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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