Status:
NOT_YET_RECRUITING
sCD163 in HELLP Syndrome
Lead Sponsor:
Assiut University
Conditions:
HELLP Syndrome Complicating Pregnancy
Eligibility:
FEMALE
18-45 years
Brief Summary
Primary Aim: \_To investigate the diagnostic potential of soluble CD163 (sCD163)as a novel biomarker for the early detection of HELLP syndrome, assessing its sensitivity and specificity compared to c...
Detailed Description
\_HELLP syndrome, also known as the syndrome of hemolysis, elevated liver enzymes, and low platelets, represents a sever pregnancy complication typically associated with hypertension. HELLP occurs in ...
Eligibility Criteria
Inclusion
- HELLP Syndrome Group:
- 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
- Gestational age (20-42) weeks
- Control Group:
- Normotensive pregnant women (BP \<140/90 mmHg, no proteinuria).
- Gestational age-matched
Exclusion
- Chronic medical conditionsaffecting sCD163 levels:
- Autoimmune diseases (e.g., lupus, rheumatoid arthritis)
- Chronic kidney/liver disease
- Active infections (e.g., HIV, hepatitis)
- Fetal anomalies or intrauterine fetal demise at diagnosis.
- Use of immunosuppressive therapies (e.g., corticosteroids beyond standard HELLP management).
- Incomplete clinical/laboratory data for HELLP classification.
- Other gestational disease such as gestational DM
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07209748
Start Date
December 1 2025
End Date
February 1 2027
Last Update
October 7 2025
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