New brain & blood test combo may spot deadly pregnancy complication earlier
NCT ID NCT02578810
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a brain wave monitor (BIS) and two blood tests (sFIT/PIGF ratio and adrenomedullin) can more accurately grade the severity of preeclampsia and eclampsia in pregnant women. Researchers will enroll 48 participants to see if these tools can predict risk better than current methods. The goal is to help doctors catch dangerous cases earlier and improve mother and baby outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Oct 2016
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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18 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medical Ethics Committee, University Malaya Medical Centre
RECRUITINGKuala Lumpur, Malaysia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Citrulline: a potential key to prolonging pregnancy in pre-eclampsia?
- Can exercise shield pregnant women from preeclampsia?
- Two proteins could give african clinics an early warning for dangerous pregnancy complication
- Can a neck ultrasound predict fluid balance in preeclampsia?
- A helping hand after pregnancy may protect hearts for years
- Postpartum blood pressure control may stop preeclampsia from leading to lifelong hypertension