HELLP Syndrome Complicating PregnancyNCT07209748
sCD163 in HELLP Syndrome
An observational study of HELLP Syndrome Complicating Pregnancy, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- HELLP Syndrome Complicating Pregnancy
- What is being tested?
- sCD163 level
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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
Who may be able to join
- 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
Show all 9Show fewer
- Control Group:
- Normotensive pregnant women (BP <140/90 mmHg, no proteinuria).
- Gestational age-matched
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Significance of Soluble CD163 as a Novel Biomarker in the Early Detection and Severity Assessment of HELLP Syndrome
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:
- To evaluate the correlation between sCD163 levels and the clinical severity of HELLP syndrome, including complications such as liver dysfunction, thrombocytopenia, and hemolysis.
- To compare sCD163 levels across different stages of HELLP syndrome (partial vs. complete and other hypertensive disorders of pregnancy (e.g., preeclampsia).
Read the 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 0.2-0.8% of pregnancies and in 70-80% of cases, it coexists with preeclampsia (PE) with a 0-24% mortality rate .Both conditions are classified as hypertensive diseases of pregnancy (HDP), and their pathogenesis has been linked to an excessive maternal inflammatory response, accompanied by enhanced endothelial activation. Erythrocytes are damaged as they pass through blood vessels with impaired endothelium and fibrin strands, resulting in microangiopathic hemolytic anemia (MAHA). Lactate dehydrogenase (LDH) concentration may rise as a consequence of hemolysis. Free hemoglobin binds to unconjugated bilirubin in the spleen or haptoglobin in plasma. Low serum haptoglobin is a characteristic in HELLP women. Patients whose pregnancies are complicated by HELLP syndrome are at a higher risk for renal failure, consumptive coagulopathy, placental abruption, pulmonary and cerebral edema, subcapsular liver hematoma, and hypovolemic shock. Maternal-fetal inflammatory responses were another critical theme , demonstrating that maternal inflammation extends to the fetal compartment, as evidenced by elevated uric acid and CRP in neonates of PE mothers predisposing offspring to long-term metabolic and cardiovascular risks. Soluble clusters of differentiation (sCD163) is a marker of activated macrophages, and its role is to modulate inflammatory reactions. sCD163 stands out as a valuable biomarker, commonly correlates the progression or the severity of several pathological conditions with its levels in tissue fluids, serum, or plasma. It's derived from enzymatic cleavage of cd163 enhanced by inflammatory response or oxidative stress. The primary function attributed to sCD163, similar to CD163, is the absorption and elimination of unbound hemoglobin, thereby reducing oxidative damage caused by heme radicals, since free hemoglobin in the blood stream can contribute to oxidative stress and tissue damage. The scavenging function of sCD163 helps to mitigate these effects. It has been demonstrated that sCD163 and immunoglobulin G interact with the free HB in plasma, leading to monocytic endocytosis of the sCD163-Hb-IgG complex via the Fcγ receptor (FcγR).
Several studies reported significant associations between inflammatory biomarkers and the risk of PE correlating with disease severity, systolic blood pressure, and proteinuria. In our study, we will test levels of sCD163 in pregnant women at different degrees of HELLP syndrome to discover their relationship\& its role in early detection of the syndrome.
- Conditions
- HELLP Syndrome Complicating Pregnancy
- Being tested
- sCD163 level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sCD163 levelDiagnostic test
The significance of soluble CD163 level in the early detection and severity assessment of HELLP Syndrome
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described Receives: Diagnostic Test: sCD163 level | |
| HELLP Syndrome group | Not described Receives: Diagnostic Test: sCD163 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HELLP Syndrome Complicating PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ragab Hamed Arafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209748
- Sponsor's protocol ID
- sCD163 in HELLP syndrome
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35208649Gardikioti 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.
PubMed 35409211Vigil-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.
PubMed 11146072Abdeldaem 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.
PubMed 40786291Plevriti 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.
PubMed 39451197
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Soluble CD163 as a Novel Biomarker in the Early Detection and Severity Assessment of HELLP Syndrome
- ClinicalTrials.gov ID
- NCT07209748
- Acronym / sponsor ID
- sCD163 in HELLP syndrome
- Conditions
- HELLP Syndrome Complicating Pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the correlation between sCD163 levels and the clinical severity of HELLP syndrome, including complications such as liver dysfunction, thrombocytopenia, and hemolysis.
- To compare sCD163 levels across different stages of HELLP syndrome (partial vs. complete and other hypertensive disorders of pregnancy (e.g., preeclampsia).
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 0.2-0.8% of pregnancies and in 70-80% of cases, it coexists with preeclampsia (PE) with a 0-24% mortality rate .Both conditions are classified as hypertensive diseases of pregnancy (HDP), and their pathogenesis has been linked to an excessive maternal inflammatory response, accompanied by enhanced endothelial activation. Erythrocytes are damaged as they pass through blood vessels with impaired endothelium and fibrin strands, resulting in microangiopathic hemolytic anemia (MAHA). Lactate dehydrogenase (LDH) concentration may rise as a consequence of hemolysis. Free hemoglobin binds to unconjugated bilirubin in the spleen or haptoglobin in plasma. Low serum haptoglobin is a characteristic in HELLP women. Patients whose pregnancies are complicated by HELLP syndrome are at a higher risk for renal failure, consumptive coagulopathy, placental abruption, pulmonary and cerebral edema, subcapsular liver hematoma, and hypovolemic shock. Maternal-fetal inflammatory responses were another critical theme , demonstrating that maternal inflammation extends to the fetal compartment, as evidenced by elevated uric acid and CRP in neonates of PE mothers predisposing offspring to long-term metabolic and cardiovascular risks. Soluble clusters of differentiation (sCD163) is a marker of activated macrophages, and its role is to modulate inflammatory reactions. sCD163 stands out as a valuable biomarker, commonly correlates the progression or the severity of several pathological conditions with its levels in tissue fluids, serum, or plasma. It's derived from enzymatic cleavage of cd163 enhanced by inflammatory response or oxidative stress. The primary function attributed to sCD163, similar to CD163, is the absorption and elimination of unbound hemoglobin, thereby reducing oxidative damage caused by heme radicals, since free hemoglobin in the blood stream can contribute to oxidative stress and tissue damage. The scavenging function of sCD163 helps to mitigate these effects. It has been demonstrated that sCD163 and immunoglobulin G interact with the free HB in plasma, leading to monocytic endocytosis of the sCD163-Hb-IgG complex via the Fcγ receptor (FcγR).
Several studies reported significant associations between inflammatory biomarkers and the risk of PE correlating with disease severity, systolic blood pressure, and proteinuria. In our study, we will test levels of sCD163 in pregnant women at different degrees of HELLP syndrome to discover their relationship\& its role in early detection of the syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: sCD163 level |
| HELLP Syndrome group | – | Diagnostic Test: sCD163 level |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (9 listed)
- HELLP Syndrome Group:
- Control Group:
Key exclusion criteria (8 listed)
- Chronic medical conditionsaffecting sCD163 levels:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sCD163 levelThe significance of soluble CD163 level in the early detection and severity assessment of HELLP Syndrome | Diagnostic test | Control group, HELLP Syndrome group |
Primary outcome
Comparison of sCD163 level in the 2 study groups
Time frame: baseline
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Background: PubMed 35208649Petca 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.
- Background: PubMed 35409211Gardikioti 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.
- Background: PubMed 11146072Vigil-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.
- Background: PubMed 40786291Abdeldaem 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.
- Background: PubMed 39451197Plevriti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of HELLP Syndrome Complicating Pregnancy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Ragab Hamed, Master (01022866965, asmaaaaaaaa99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of sCD163 level in the 2 study groups (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07209748, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.