PIERS and BIS, sFIT:PIGF, Adrenomedullin

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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02578810

Acronym

BIS2

Enrollment

Registered

2015-10-19

Start date

2016-10-01

Completion date

2030-12-01

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eclampsia

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Decline in BIS	we will record Bispectral Index (BIS) for a quite 20 min no tactile contact or noise that could raise the BIS inadvertently	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

Countries

Malaysia

Contacts

CONTACTAshraf Dahaba, MD

ashraf.dahaba@medunigraz.at00436509006761

PRINCIPAL_INVESTIGATORAshraf Dahaba, MD

Guest Professor

Outcome results