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

NCT02351583 | Withdrawn

• 1 other identifier: 17837
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Eclampsia

Outcome Measures

Primary Outcomes (2)

• Assessment of microcirculatory changes by sidestream darkfield microscopy (SDF)

  To assess whether sidestream darkfield microscopy (SDF) and could detect microcirculatory changes in patients who developed preeclampsia versus those who do not.

  Day 1

• Tissue oxygenation assessed using Near-infra-red spectroscopy (NIRS)

  Near-infra-red spectroscopy (NIRS),

  Day 1

Study Arms (2)

preclampsia

10 with diagnosis of preeclampsia will be examined with both NIRS and cytocam to obtain data

Device: CytoCam; Device: NIRS Artinis PortaLite with OxySoft softwear

normal pregnancy

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

Device: CytoCam; Device: NIRS Artinis PortaLite with OxySoft softwear

Interventions

CytoCam DEVICE

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.

normal pregnancy; preclampsia

NIRS Artinis PortaLite with OxySoft softwear DEVICE

. 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; preclampsia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• patients with:
• diabetes,
• gestational diabetes,
• gestational hypertension,
• chronic hypertension,
• chorioamniotitis

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (11)

• Naljayan MV, Karumanchi SA. New developments in the pathogenesis of preeclampsia. Adv Chronic Kidney Dis. 2013 May;20(3):265-70. doi: 10.1053/j.ackd.2013.02.003.

  PMID: 23928392 BACKGROUND

• Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.

  PMID: 18177778 BACKGROUND

• Khan F, Belch JJ, MacLeod M, Mires G. Changes in endothelial function precede the clinical disease in women in whom preeclampsia develops. Hypertension. 2005 Nov;46(5):1123-8. doi: 10.1161/01.HYP.0000186328.90667.95. Epub 2005 Oct 17.

  PMID: 16230524 BACKGROUND

• Anim-Nyame N, Gamble J, Sooranna SR, Johnson MR, Sullivan MH, Steer PJ. Evidence of impaired microvascular function in pre-eclampsia: a non-invasive study. Clin Sci (Lond). 2003 Apr;104(4):405-12.

  PMID: 12653685 BACKGROUND

• Nama V, Manyonda IT, Onwude J, Antonios TF. Structural capillary rarefaction and the onset of preeclampsia. Obstet Gynecol. 2012 May;119(5):967-74. doi: 10.1097/AOG.0b013e31824ea092.

  PMID: 22525907 BACKGROUND

• Pennings FA, Ince C, Bouma GJ. Continuous real-time visualization of the human cerebral microcirculation during arteriovenous malformation surgery using orthogonal polarization spectral imaging. Neurosurgery. 2006 Jul;59(1):167-71; discussion 167-71. doi: 10.1227/01.NEU.0000219242.92669.3B.

  PMID: 16823313 BACKGROUND

• Mathura KR, Bouma GJ, Ince C. Abnormal microcirculation in brain tumours during surgery. Lancet. 2001 Nov 17;358(9294):1698-9. doi: 10.1016/S0140-6736(01)06722-8.

  PMID: 11728549 BACKGROUND

• Perez-Barcena J, Goedhart P, Ibanez J, Brell M, Garcia R, Llinas P, Jimenez C, Ince C. Direct observation of human microcirculation during decompressive craniectomy after stroke. Crit Care Med. 2011 May;39(5):1126-9. doi: 10.1097/CCM.0b013e31820ead5e.

  PMID: 21317640 BACKGROUND

• Sitina M, Turek Z, Parizkova R, Cerny V. In situ assessment of the brain microcirculation in mechanically-ventilated rabbits using sidestream dark-field (SDF) imaging. Physiol Res. 2011;60(1):75-81. doi: 10.33549/physiolres.931937. Epub 2010 Oct 15.

  PMID: 20945959 BACKGROUND

• Diedler J, Zweifel C, Budohoski KP, Kasprowicz M, Sorrentino E, Haubrich C, Brady KM, Czosnyka M, Pickard JD, Smielewski P. The limitations of near-infrared spectroscopy to assess cerebrovascular reactivity: the role of slow frequency oscillations. Anesth Analg. 2011 Oct;113(4):849-57. doi: 10.1213/ANE.0b013e3182285dc0. Epub 2011 Aug 4.

  PMID: 21821514 BACKGROUND

• Yamazaki K, Suzuki K, Itoh H, Muramatsu K, Nagahashi K, Tamura N, Uchida T, Sugihara K, Maeda H, Kanayama N. Cerebral oxygen saturation evaluated by near-infrared time-resolved spectroscopy (TRS) in pregnant women during caesarean section - a promising new method of maternal monitoring. Clin Physiol Funct Imaging. 2013 Mar;33(2):109-16. doi: 10.1111/cpf.12001. Epub 2012 Sep 23.

  PMID: 23383688 BACKGROUND

MeSH Terms

Conditions

Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mohamed Tiouririne, MD

  University of Virginia Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Anesthesiology

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 30, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)