PIERS and BIS, sFIT:PIGF, Adrenomedullin

Recruiting

• Conditions: Eclampsia

• Registration Number: NCT02578810
• Lead Sponsor: Suez Canal University

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.

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Study Start: 2016-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Ethics Committee, University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia