PIERS and BIS, sFIT:PIGF, Adrenomedullin

Eclampsia Clinical Trial

— BIS2  

Official title:

Sensitivity and Specificity of Bispectral Index (BIS) EEG Parameter, sFIT (Soluble FMS Tyrosine Kinase): PIGF (Placental Growth Factor) Ratio, Adrenomedullin for Grading Preeclampsia Integrated Estimate Risk Score (PIERS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02578810
• Other study ID #: MUGraz2
• Status: Recruiting
• Start date: October 2016
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Suez Canal University
• Contact: Ashraf Dahaba, MD
• Phone: 00436509006761
• Email: ashraf.dahaba[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia

Locations

Country	Name	City	State
Malaysia	Medical Ethics Committee, University Malaya Medical Centre	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Suez Canal University	University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decline in BIS	our hypothesis is that a decline of Bispectral Index (BIS) assuming to be in the range of 15-60 will correlate to the with a high PIERS we can then quantify this BIS decline maybe in 4 Eclampsia grades	we will record Bispectral Index (BIS) for a quite 20 min no tactile contact or noise that could raise the BIS inadvertently