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Trial record 31 of 31 for:    "Preeclampsia/eclampsia 1" | "Antihypertensive Agents"

PIERS and BIS, sFIT:PIGF, Adrenomedullin (BIS2)

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ClinicalTrials.gov Identifier: NCT02578810
Recruitment Status : Recruiting
First Posted : October 19, 2015
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Ashraf Dahaba, MD, 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.

Condition or disease
Eclampsia

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.


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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Prospective
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)
Study Start Date : October 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Eclampsia
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.
Control
In 24 control patients without 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



Primary Outcome Measures :
  1. Decline in BIS [ Time Frame: 20 min recording period ]
    a lower BIS might correlate with a high PIERS



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria

  1. Pregnancy
  2. Eclampsia
  3. Pre-eclampsia

Exclusion criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578810


Contacts
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Contact: Ashraf Dahaba, MD 00436509006761 ashraf.dahaba@medunigraz.at

Locations
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Malaysia
Medical Ethics Committee, University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia
Contact: Ashraf Dahaba       ashraf.dahaba@medunigraz.at   
Sponsors and Collaborators
Suez Canal University
University of Malaya
Investigators
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Principal Investigator: Ashraf Dahaba, MD Guest Professor

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Responsible Party: Ashraf Dahaba, MD, Principle Investigator, Suez Canal University
ClinicalTrials.gov Identifier: NCT02578810     History of Changes
Other Study ID Numbers: MUGraz2
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Antihypertensive Agents
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Adrenomedullin
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Vasodilator Agents
Protective Agents