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Recruiting NCT02578810

PIERS and BIS, sFIT:PIGF, Adrenomedullin

Conditions: Eclampsia

Sponsor: Suez Canal University

trial.available_in: БГ
Overview
Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity and mortality worldwide.1 Standardization of antenatal and postnatal assessment and surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model of preeclampsia have been associated with reduced maternal morbidity.
Description
Background: Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity and mortality worldwide.1 Standardization of antenatal and postnatal assessment and surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model of preeclampsia have been associated with reduced maternal morbidity.2 To quantitatively asses electroencephalography (EEG) mental involvement in Pre-eclampsia is still time consuming and not always readily available. PIERS was developed and internally validate as a pre-eclampsia outcome prediction model- (Preeclampsia Integrated Estimate of RiSk) model.3 The purpose of our study was to evaluate the discriminative power of the Bispectral Index (BIS), biomarkers sFIT (soluble FMS-like Tyrosine Kinase): PIGF (Placental Growth Factor) ratio,4 and adrenomedullin mortality risk stratifier,5 to classify the degree and progression of pre-eclampsia. Methods: In 24 patients with Eclampsia or pre-eclampsia investigators will use an artefact-free 20-min mean BIS value, as well as biomarkers sFIT (soluble FMS-like Tyrosine Kinase): PIGF (Placental Growth Factor) ratio and adrenomedullin mortality risk stratifier to classify the degree of pre-eclampsia correlated the PIERS Pre-eclampsia risk assessment PIERS percentage (http://piers.cfri.ca/PIERSCalculatorH.aspx) will be calculated from patients' clinical and laboratory findings documented in their charts, compared with 24 pregnant patients without Eclampsia or pre-eclampsia.
Who can participate
Inclusion Criteria 1. Pregnancy at any stage (3 trimesters) 2. Eclampsia (Frank eclampsia) will be the crux of the study 3. Pre-eclampsia that is suspected will end up with Frank Eclampsia Exclusion criteria: 1. Any neurological conditions that can alter the electroencephalography like epilepsy 2. Any medical conditions that can alter the electroencephalography like hypoglycemia
Locations 1
Malaysia (1)
Medical Ethics Committee, University Malaya Medical Centre
Kuala Lumpur
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
50 Years
Healthy volunteers
No
Start date
01.10.2016
Completion date
01.12.2030
Registry ID
NCT02578810
Source
clinicaltrials.gov
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