sCD163 in HELLP Syndrome

ConditionHELLP Syndrome Complicating Pregnancy

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18-45

SponsorAssiut University

About this trial

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 current diagnostic markers.

Secondary Aims:

1. To evaluate the correlation between sCD163 levels and the clinical severity of HELLP syndrome, including complications such as liver dysfunction, thrombocytopenia, and hemolysis. 2. To compare sCD163 levels across different stages of HELLP syndrome (partial vs. complete and other hypertensive disorders of pregnancy (e.g., preeclampsia).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

* 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

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

sCD163 level
Diagnostic test
The significance of soluble CD163 level in the early detection and severity assessment of HELLP Syndrome

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Control group1 intervention

Group B: HELLP Syndrome group1 intervention

Trial outcomes

Primary outcomes

Comparison of sCD163 level in the 2 study groups

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 current diagnostic markers and evaluate the correlation between sCD163 levels and the clinical severity of HELLP syndrome

Time frame

baseline

Locations

This trial has no locations.

Sponsors and contacts

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

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: