Simple blood test may spot Life-Threatening HELLP syndrome sooner
NCT ID NCT07209748
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a substance in the blood called sCD163 can help doctors find HELLP syndrome early in pregnant women. HELLP is a rare but serious condition that can harm the liver and blood. Researchers will compare sCD163 levels in 70 pregnant women—some with HELLP and some healthy—to see if the test is accurate and can tell how severe the condition is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sCD163 level (diagnostic test)
- What this could lead to
- If successful, this could lead to a simple blood test that helps doctors detect HELLP syndrome earlier and more accurately, potentially improving outcomes for pregnant women.
- What could go wrong
- This is a small, early-stage study with only 70 participants, so results may not apply to all patients. The test may not prove reliable enough to replace current methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
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
* HELLP Syndrome Group: 1. Pregnant women meeting complete HELLP criteria: * Hemolysis (LDH \>600 U/L + abnormal smear or bilirubin ≥1.2 mg/dL) * AST/ALT ≥70 U/L * Platelets \<100,000/μL 2. Gestational age (20-42) weeks * Control Group: 1. Normotensive pregnant women (BP \<140/90 mmHg, no proteinuria). 2. Gestational age-matched
- Ages
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18 to 45 years
- Sex
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Female participants only
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * HELLP Syndrome Group: 1. Pregnant women meeting complete HELLP criteria: * Hemolysis (LDH \>600 U/L + abnormal smear or bilirubin ≥1.2 mg/dL) * AST/ALT ≥70 U/L * Platelets \<100,000/μL 2. Gestational age (20-42) weeks * Control Group: 1. Normotensive pregnant women (BP \<140/90 mmHg, no proteinuria). 2. Gestational age-matched Exclusion Criteria: 1. Chronic medical conditionsaffecting sCD163 levels: * Autoimmune diseases (e.g., lupus, rheumatoid arthritis) * Chronic kidney/liver disease * Active infections (e.g., HIV, hepatitis) 2. Fetal anomalies or intrauterine fetal demise at diagnosis. 3. Use of immunosuppressive therapies (e.g., corticosteroids beyond standard HELLP management). 4. Incomplete clinical/laboratory data for HELLP classification. 5. Other gestational disease such as gestational DM
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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 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.