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

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ClinicalTrials.gov Identifier: NCT02351583
Recruitment Status : Unknown
Verified May 2016 by Mohamed Tiouririne, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : January 30, 2015
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Mohamed Tiouririne, MD, University of Virginia

Brief 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.


Condition or disease Intervention/treatment
Pregnancy Eclampsia Device: CytoCam Device: NIRS Artinis PortaLite with OxySoft softwear

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Microcirculatory and Tissue and Cerebral Oxygenation Differences Between Preeclampsia and Normal Pregnancy: An Observation Study
Study Start Date : January 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
preclampsia
10 with diagnosis of preeclampsia will be examined with both NIRS and cytocam to obtain data
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.

normal pregnancy
10 with normal pregnancy will be examined with both NIRS and cytocam to obtain data
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.




Primary Outcome Measures :
  1. Assessment of microcirculatory changes by sidestream darkfield microscopy (SDF) [ Time Frame: Day 1 ]
    To assess whether sidestream darkfield microscopy (SDF) and could detect microcirculatory changes in patients who developed preeclampsia versus those who do not.

  2. Tissue oxygenation assessed using Near-infra-red spectroscopy (NIRS) [ Time Frame: Day 1 ]
    Near-infra-red spectroscopy (NIRS),



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Age 18 years and older females (10 with diagnosis of preeclampsia and 10 with normal pregnancy), planned to deliver at UVA
Criteria

Inclusion Criteria:

  • Age 18 years and older females (10 with diagnosis of preeclampsia and 10 with normal pregnancy),
  • planned to deliver at UVA

Exclusion Criteria:

patients with:

  • diabetes,
  • gestational diabetes,
  • gestational hypertension,
  • chronic hypertension,
  • chorioamniotitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351583


Contacts
Contact: Marcia E Birk, RN 434-924-2283 meb2w@virginia.edu
Contact: Mohamed Tiouririne ,, MD 434-924-2283 mt9y@Virginia.EDU

Locations
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Mohamed Tiouririne, MD University of Virginia Department of Anesthesiology

Publications:

Responsible Party: Mohamed Tiouririne, MD, Associate Professor, Anesthesiology, University of Virginia
ClinicalTrials.gov Identifier: NCT02351583     History of Changes
Other Study ID Numbers: 17837
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications