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PIERS and BIS, sFIT:PIGF, Adrenomedullin

NCT ID: NCT02578810

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Eclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role collaborator

Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Ashraf A. Dahaba

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashraf Dahaba, MD

Role: PRINCIPAL_INVESTIGATOR

Guest Professor

Locations

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Medical Ethics Committee, University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Ashraf Dahaba, MD

Role: CONTACT

[email protected]
00436509006761

Facility Contacts

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Ashraf Dahaba

Role: primary

[email protected]

Other Identifiers

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MUGraz2

Identifier Type: -

Identifier Source: org_study_id