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Microcirculatory and Tissue and Cerebral Oxygenation in Preeclampsia and Normal Pregnancy: An Observation Study

NCT02351583 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-03-24

No results posted yet for this study

Summary

Preeclampsia is a disease of pregnancy affecting 3% to 8% of all pregnancies and is a major cause of maternal and perinatal morbidity and mortality. Characterized by alter placentation with subsequent release of inflammatory mediators leading to a generalized endothelial dysfunction. It is now accepted that endothelial dysfunction heralds the clinical manifestations of preeclampsia.

The side-stream darkfield (SDF) microscopy device emits a 550 nm green light with a depth region of interest of 500 um. Green light is absorbed by the erythrocytes and appears black. SDF is a well-known non-invasive tool that can study the microcirculatory changes. It was used before in many situations especially in sepsis and septic shock patients.

Near-infra-red spectroscopy (NIRS) device, measures the absorbance of near-infra-red (NIR) light by tissues perfused with oxygenated blood, and is capable of measuring changes in parenchymal volume tissues. It was used before in many situations (including pregnant patients) to reflect the tissue oxygenations.

The investigators are planning to use the SDF and NIRS tools to study the microcirculatory change in preeclamptic subjects and normal pregnant subjects. If these two devices are able to determine any changes this should stand as a baseline for future studies in this field.

Conditions

  • Pregnancy
  • Eclampsia

Interventions

DEVICE

CytoCam

The side-stream darkfield camera ( CytoCam) will be put under the subjects tongue for 5-10 minutes. Multiple pictures of the small blood vessels will be taken.

DEVICE

NIRS Artinis PortaLite with OxySoft softwear

. The NIRS probe will be applied to one of the patient's thenar muscle and over the patient forehead and tissue oxygenation (TOI) will be recorded for 5 minutes.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Mohamed Tiouririne, MD · University of Virginia Department of Anesthesiology

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2017-06-01
Completion
2017-06-01

Countries

  • United States

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 NCT02351583 on ClinicalTrials.gov