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RecruitingNCT02578810BIS2Updated Apr 23, 2026

PIERS and BIS, sFIT:PIGF, Adrenomedullin

An observational study in Eclampsia, sponsored by Suez Canal University. Recruiting at 1 site in Malaysia. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Suez Canal University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
48
Ages
18 Years to 50 Years
Sex
Female
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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.

Read the 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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Conditions studied

  • Eclampsia

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03

In context

Eclampsia

76 studies on the registry are indexed under Eclampsia; 13 are open to participants now.

This study's planned enrollment of 48 is below the median of 282 across 34 observational studies indexed under Eclampsia.

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Lead sponsor

Suez Canal University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
48 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Decline in BIS

    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

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

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Study locations

1 of 1 sites recruiting
  • Medical Ethics Committee, University Malaya Medical Centre
    Kuala Lumpur, Malaysia
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02578810
Responsible party
Ashraf A. Dahaba (Principle Investigator, Suez Canal University) — Principal investigator
First posted
Oct 19, 2015
Start date
Oct 2016
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Apr 23, 2026

Study contacts

Ashraf Dahaba, MD
Contact
ashraf.dahaba@medunigraz.at
00436509006761
Ashraf Dahaba, MD
principal investigator · Guest Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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