NCT07209748

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 current diagnostic markers. Secondary Aims:

  1. 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. 2.To compare sCD163 levels across different stages of HELLP syndrome (partial vs. complete and other hypertensive disorders of pregnancy (e.g., preeclampsia).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Dec 2025Feb 2027

First Submitted

Initial submission to the registry

September 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 30, 2025

Last Update Submit

September 30, 2025

Conditions

HELLP Syndrome Complicating Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline

Study Arms (2)

Control group

Diagnostic Test: sCD163 level

HELLP Syndrome group

Diagnostic Test: sCD163 level

Interventions

sCD163 levelDIAGNOSTIC_TEST

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

Control groupHELLP Syndrome group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Petca A, Miron BC, Pacu I, Dumitrascu MC, Mehedintu C, Sandru F, Petca RC, Rotar IC. HELLP Syndrome-Holistic Insight into Pathophysiology. Medicina (Kaunas). 2022 Feb 21;58(2):326. doi: 10.3390/medicina58020326.

    PMID: 35208649BACKGROUND

  • Gardikioti A, Venou TM, Gavriilaki E, Vetsiou E, Mavrikou I, Dinas K, Daniilidis A, Vlachaki E. Molecular Advances in Preeclampsia and HELLP Syndrome. Int J Mol Sci. 2022 Mar 31;23(7):3851. doi: 10.3390/ijms23073851.

    PMID: 35409211BACKGROUND

  • Vigil-De Gracia P. Pregnancy complicated by pre-eclampsia-eclampsia with HELLP syndrome. Int J Gynaecol Obstet. 2001 Jan;72(1):17-23. doi: 10.1016/s0020-7292(00)00281-2.

    PMID: 11146072BACKGROUND

  • Abdeldaem Mohamed RH, Ahmed Ali Alfaki NM, Belal RE, Ali Dawelbait AM, Hamad Yousif RB, Mohamed SAE, Badre Adam HS, Abbashar Abdelmahmoud EM. Biomarkers of Inflammation and Their Association With the Severity and Onset of Preeclampsia: A Systematic Review. Cureus. 2025 Jul 11;17(7):e87734. doi: 10.7759/cureus.87734. eCollection 2025 Jul.

    PMID: 40786291BACKGROUND

  • Plevriti A, Lamprou M, Mourkogianni E, Skoulas N, Giannakopoulou M, Sajib MS, Wang Z, Mattheolabakis G, Chatzigeorgiou A, Marazioti A, Mikelis CM. The Role of Soluble CD163 (sCD163) in Human Physiology and Pathophysiology. Cells. 2024 Oct 11;13(20):1679. doi: 10.3390/cells13201679.

    PMID: 39451197BACKGROUND

Central Study Contacts

Asmaa Ragab Hamed, Master

CONTACT

01022866965asmaaaaaaaa99@gmail.com

Amal Abd EL Aziz Mahmoud

CONTACT

01005184823Amal11068@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 7, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

October 7, 2025

Record last verified: 2025-09