Evaluating biomarkers and EEG in pre-eclampsia and eclampsia
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)
This study is trying to see if certain blood markers and brain activity can help doctors understand the severity of pre-eclampsia and eclampsia in pregnant women to better predict risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Suez Canal University Academic / other |
| Locations | 1 site (Kuala Lumpur) |
| Trial ID | NCT02578810 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the discriminative power of the Bispectral Index (BIS), the soluble FMS-like Tyrosine Kinase to Placental Growth Factor (sFIT:PIGF) ratio, and adrenomedullin as mortality risk stratifiers in patients with eclampsia or pre-eclampsia. By analyzing these biomarkers and EEG data, the study seeks to classify the severity and progression of pre-eclampsia, which is a significant cause of maternal morbidity and mortality. The study will involve 24 patients and will utilize a standardized risk assessment model known as PIERS to correlate clinical findings with the degree of pre-eclampsia.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals at any stage who are diagnosed with eclampsia or suspected of having pre-eclampsia.
Not a fit: Patients with neurological or medical conditions that could affect electroencephalography results, such as epilepsy or hypoglycemia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of pre-eclampsia, potentially reducing maternal morbidity and mortality.
How similar studies have performed: While the approach of using biomarkers and EEG in this context is innovative, similar studies have shown promise in improving outcomes for pre-eclampsia management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kuala Lumpur
- Medical Ethics Committee, University Malaya Medical Centre — Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Ashraf Dahaba, MD — Guest Professor
- Study coordinator: Ashraf Dahaba, MD
- Email: ashraf.dahaba@medunigraz.at
- Phone: 00436509006761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.