PIERS and BIS, sFIT:PIGF, Adrenomedullin

ConditionEclampsia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18-50

SponsorSuez Canal University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Pregnancy at any stage (3 trimesters)

Eclampsia (Frank eclampsia) will be the crux of the study

Pre-eclampsia that is suspected will end up with Frank Eclampsia

Disqualifiers

Any neurological conditions that can alter the electroencephalography like epilepsy

Any medical conditions that can alter the electroencephalography like hypoglycemia

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

48 Participants

are grouped into 2 trial groups

Group A: Eclampsia

Group B: Control

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suez Canal University

Lead sponsor

University of Malaya

Collaborator

Source ClinicalTrials.gov

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