PIERS and BIS, sFIT:PIGF, Adrenomedullin

Last updated: November 21, 2023
Sponsor: Suez Canal University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Treatment

N/A

Clinical Study ID

NCT02578810
MUGraz2
  • Ages 18-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion criteria:

  1. Any neurological conditions that can alter the electroencephalography like epilepsy
  2. Any medical conditions that can alter the electroencephalography like hypoglycemia

Study Design

Total Participants: 48
Study Start date:
October 01, 2016
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Medical Ethics Committee, University Malaya Medical Centre

    Kuala Lumpur,
    Malaysia

    Active - Recruiting

  • Medical Ethics Committee, University Malaya Medical Centre

    Kula Lumpur,
    Malaysia

    Site Not Available

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