HELLP SyndromeNCT07377786
Study of Prognostic Values of Platelet Indices and Inflammatory Markers in Patients With HELLP Syndrome.
An observational study of HELLP Syndrome, run by Sohag University.
Trial summary
This study aims to evaluate the prognostic values of platelet indices and inflammatory markers in patients with HELLP syndrome as:- :-Primary outcome To investigate prognostic values of platelet indices and. . inflammatory markers in HELLP syndrome patients as main indices including (NLR-PLR-MPV-PDW and RDW). . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HELLP Syndrome
- What is being tested?
- Group I: 30 patients with HELLP syndrome
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to Dec 2026
- How long will I take part?
- 2 Days
- 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
- Healthy volunteers accepted
- Adult
Study population: Patients with HELLP syndrome in surgical intensive care unit
Who may be able to join
- Pregnant women aged 18 and 45 years. Gestational age ranged from 28 to 41 weeks. Pregnant women diagnosed with HELLP syndrome. Preeclampsia with Hellp syndrome. Pt with HELLP syndrome was delivered by ceserian section(SC)then admitted to Intensive care unit (ICU) only normal singleton pregnancies without fetal congenital or chromosomal anomalies
Who cannot join
- Patients with infection and fever. Women with a history of diabetes, hypertension, systemic or endocrine disorder, chronic infection, chronic renal disease Liver diseases. Blood diseases. Drugs affecting platelet counts or functions. Any history of membrane rupture
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: Prognostic Values of Platelet Indices and Inflammatory Markers in Patients With HELLP Syndrome( Observational Controlled Study)
This study aims to evaluate the prognostic values of platelet indices and inflammatory markers in patients with HELLP syndrome as:- :-Primary outcome To investigate prognostic values of platelet indices and. . inflammatory markers in HELLP syndrome patients as main indices including (NLR-PLR-MPV-PDW and RDW). .
-Secondary outcome. Evaluation complications of HELLP syndrome including. .
- Maternal complication:- eclampsia, disseminated intravascular coagulation (DIC), liver rupture, placental abruption, stroke, and pulmonary or kidney failure. .
- Fetal complication:-intra uterine fetal death(iufd) ,neonate need for admission to NICU , congintal anomalies .assess APGAR score (which assess appearance(skin color)-pulse(heart rate)-Grimace(reflex irritability)- Activity(muscle tone)-Respiratory(breathing efforts) or umblical cord PH<7. .
Read the detailed description
Hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome is a severe complication in the third trimester of pregnancy. First described by Weinstein in 1982(1)
- HELLP syndrome occurs in up to 0.9% of all pregnancies in the third trimester or in the immediate postpartum period (2)
Associated with adverse pregnancy outcomes, the maternal and perinatal mortality rates of HELLP syndrome may reach up to 23.1% and 56.9% respectively, which is life threatening to both the gravida and the fetus(3)
- Usually, patients develop HELLP syndrome before 36 weeks of gestation with vague symptoms such as malaise (90%), right-upper-quadrant pain (90%), nausea, or vomiting(4)
Preeclampsia (PE) constitutes one of the principal reasons for maternal and perinatal morbidity and mortality worldwide. The circumstance typically implicates formerly healthful normotensive women, after 20 weeks of gestation, typically withinside the third trimester, without regarded threat elements or past deliveries. PE can be further complicated with hemolysis and thrombocytopenia, leading to the emergence of HELLP syndrome. 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(5)
. The pathogenesis of HELLP is not fully understood. The findings of this multisystem disease are attributed to abnormal vascular tone, vasospasm and coagulation defects. So far, no common precipitating factor has been found. The syndrome seems to be the final manifestation of some insult that leads to microvascular endothelial damage and intravascular platelet activation (6)
- With platelet activation, thromboxane A and serotonin are released, causing vasospasm, platelet agglutination and aggregations, and further endothelial damage. Thus begins a cascade that is only terminated with delivery(7)
Early detection and accurate diagnosis are essential for correct management. The maternal symptoms may be vague and easily mistaken for a variety of medical or obstetric complications which should be excluded. There are two main diagnostic definitions of the HELLP syndrome. The widely used Tennessee classification requires the presence of (1) microangiopathic hemolytic anemia with abnormal blood smear, low serum haptoglobin and elevated LDH levels, (2) elevation of ASAT above 70 IU/L and LD above 600 IU/L (both enzyme levels more than twice the upper limit of normal values) or bilirubin more than 1.2 mg/dL, and (3) a platelet count below 100 109 L1(8) . HELLP syndrome implies impaired placentation during the early stages of pregnancy, associated with hepatic and coagulation cascade involvement. Coagulation system is activated by the contact of platelets with the injured endothelium leading to increase in consumption as well as bone marrow production of platelets. Raised mean platelet volume (MPV) and platelet distribution width (PDW) have been shown to be correlated with severity of the disease, whenever there is decreased PLT count (9)
. The inflammatory reaction in HELLP syndrome is more severe, but studies on the levels of inflammatory indices [e.g., neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), MPV, PDW, monocyte-to-lymphocyte ratio (MLR)] in HELLP patients have rarely been reported. As NLR, calculated by dividing the absolute neutrophil count by the lymphocyte count, reflects the balance between innate (neutrophil-mediated) and adaptive (lymphocyte-mediated) immunity, with elevated values indicating heightened inflammatory activity. PLR, obtained by dividing platelet count by lymphocyte count, integrates the pro-thrombotic and inflammatory roles of platelets with immune regulation. MLR, the ratio of monocytes to lymphocytes, is considered a marker of chronic inflammation and monocyte activation. MPV represents the average size of circulating platelets and serves as an indicator of platelet activation, while PDW measures the variability in platelet size reflecting heterogeneity in platelet production and turnover (10)
. Sisti et al (11, 12)found that the NLR was higher and the PLR was lower in patients with HELLP syndrome in the third trimester, but these indices in the first trimester did not predict the occurrence of HELLP in the third trimester. Only a relatively small number of cases were included in previous studies on this topic and no simultaneous comparison of normal pregnancies and HELLP was found (13, 14)
.
- Conditions
- HELLP Syndrome
- Being tested
- Group I: 30 patients with HELLP syndrome
- Medical subject headings
- HELLP Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I: 30 patients with HELLP syndromeDiagnostic test
All patients will be subjected to the following in ICU through 48 hrs
Detailed medical history taking:
Demographic data (age, weight, height, body mass index (BMI). Physical examination (conscious level-vital signs) Type of anesthesia (spinal -general anesthesia) Number of pregnancies, parity, history of previous pregnancies, smoking status, and history of assisted reproductive treatments.
Laboratory investigations, indices and inflammatory markers:
will be obtained after delivery, once the patient is admitted to the intensive care unit. Complete blood counts (CBC). Biochemical analyses [such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), albumin ,bilirubin and creatinine]. The indices include platelet count (PC), MPV, PDW, and plateletcrit (PCT), among these, PDW, an indicator of platelet size heterogeneity, is a marker of platelet function. It is being evaluated as a potential indicator for the risk prediction of
| Study group | Role | What they receive |
|---|---|---|
| HELLP syndrome group | Pregnant patients diagnosed with HELLP syndrome enrolled prospectively to evaluate platelet indices and inflammatory markers and their prognostic value on maternal and clinical outcomes. Receives: Diagnostic Test: Group I: 30 patients with HELLP syndrome | |
| Healthy pregnant controlled group | Healthy pregnant women without hypertensive disorders of pregnancy recruited as a control group for comparison. Receives: Diagnostic Test: Group I: 30 patients with HELLP syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study aims to evaluate the prognostic values of platelet indices and inflammatory markers in patients with HELLP syndrome
To investigate prognostic values of platelet indices and. . inflammatory markers in HELLP syndrome patients as main indices including (NLR-PLR-MPV-PDW and RDW)
Measured: 48Hours
Secondary outcomes (1)
Evaluation complications of HELLP syndrome
Maternal complication:- eclampsia, disseminated intravascular coagulation (DIC), liver rupture, placental abruption, stroke, and pulmonary or kidney failure. .
*Fetal complication:-intra uterine fetal death(iufd) ,neonate need for admission to NICU , congintal anomalies .assess APGAR score (which assess appearance(skin color)-pulse(heart rate)-Grimace(reflex irritability)- Activity(muscle tone)-Respiratory(breathing efforts) or umblical cord PH<7. .
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELLP SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Jaheen Ali, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377786
- Sponsor's protocol ID
- Soh-Med-25-12-9MS
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Values of Platelet Indices and Inflammatory Markers in Patients With HELLP Syndrome( Observational Controlled Study)
- ClinicalTrials.gov ID
- NCT07377786
- Acronym / sponsor ID
- Soh-Med-25-12-9MS
- Conditions
- HELLP Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jan 2026 (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.
This study aims to evaluate the prognostic values of platelet indices and inflammatory markers in patients with HELLP syndrome as:- :-Primary outcome To investigate prognostic values of platelet indices and. . inflammatory markers in HELLP syndrome patients as main indices including (NLR-PLR-MPV-PDW and RDW). .
-Secondary outcome. Evaluation complications of HELLP syndrome including. .
- Maternal complication:- eclampsia, disseminated intravascular coagulation (DIC), liver rupture, placental abruption, stroke, and pulmonary or kidney failure. .
- Fetal complication:-intra uterine fetal death(iufd) ,neonate need for admission to NICU , congintal anomalies .assess APGAR score (which assess appearance(skin color)-pulse(heart rate)-Grimace(reflex irritability)- Activity(muscle tone)-Respiratory(breathing efforts) or umblical cord PH<7. .
Detailed description
Hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome is a severe complication in the third trimester of pregnancy. First described by Weinstein in 1982(1)
- HELLP syndrome occurs in up to 0.9% of all pregnancies in the third trimester or in the immediate postpartum period (2)
Associated with adverse pregnancy outcomes, the maternal and perinatal mortality rates of HELLP syndrome may reach up to 23.1% and 56.9% respectively, which is life threatening to both the gravida and the fetus(3)
- Usually, patients develop HELLP syndrome before 36 weeks of gestation with vague symptoms such as malaise (90%), right-upper-quadrant pain (90%), nausea, or vomiting(4)
Preeclampsia (PE) constitutes one of the principal reasons for maternal and perinatal morbidity and mortality worldwide. The circumstance typically implicates formerly healthful normotensive women, after 20 weeks of gestation, typically withinside the third trimester, without regarded threat elements or past deliveries. PE can be further complicated with hemolysis and thrombocytopenia, leading to the emergence of HELLP syndrome. 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(5)
. The pathogenesis of HELLP is not fully understood. The findings of this multisystem disease are attributed to abnormal vascular tone, vasospasm and coagulation defects. So far, no common precipitating factor has been found. The syndrome seems to be the final manifestation of some insult that leads to microvascular endothelial damage and intravascular platelet activation (6)
- With platelet activation, thromboxane A and serotonin are released, causing vasospasm, platelet agglutination and aggregations, and further endothelial damage. Thus begins a cascade that is only terminated with delivery(7)
Early detection and accurate diagnosis are essential for correct management. The maternal symptoms may be vague and easily mistaken for a variety of medical or obstetric complications which should be excluded. There are two main diagnostic definitions of the HELLP syndrome. The widely used Tennessee classification requires the presence of (1) microangiopathic hemolytic anemia with abnormal blood smear, low serum haptoglobin and elevated LDH levels, (2) elevation of ASAT above 70 IU/L and LD above 600 IU/L (both enzyme levels more than twice the upper limit of normal values) or bilirubin more than 1.2 mg/dL, and (3) a platelet count below 100 109 L1(8) . HELLP syndrome implies impaired placentation during the early stages of pregnancy, associated with hepatic and coagulation cascade involvement. Coagulation system is activated by the contact of platelets with the injured endothelium leading to increase in consumption as well as bone marrow production of platelets. Raised mean platelet volume (MPV) and platelet distribution width (PDW) have been shown to be correlated with severity of the disease, whenever there is decreased PLT count (9)
. The inflammatory reaction in HELLP syndrome is more severe, but studies on the levels of inflammatory indices [e.g., neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), MPV, PDW, monocyte-to-lymphocyte ratio (MLR)] in HELLP patients have rarely been reported. As NLR, calculated by dividing the absolute neutrophil count by the lymphocyte count, reflects the balance between innate (neutrophil-mediated) and adaptive (lymphocyte-mediated) immunity, with elevated values indicating heightened inflammatory activity. PLR, obtained by dividing platelet count by lymphocyte count, integrates the pro-thrombotic and inflammatory roles of platelets with immune regulation. MLR, the ratio of monocytes to lymphocytes, is considered a marker of chronic inflammation and monocyte activation. MPV represents the average size of circulating platelets and serves as an indicator of platelet activation, while PDW measures the variability in platelet size reflecting heterogeneity in platelet production and turnover (10)
. Sisti et al (11, 12)found that the NLR was higher and the PLR was lower in patients with HELLP syndrome in the third trimester, but these indices in the first trimester did not predict the occurrence of HELLP in the third trimester. Only a relatively small number of cases were included in previous studies on this topic and no simultaneous comparison of normal pregnancies and HELLP was found (13, 14)
.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HELLP syndrome group | – | Diagnostic Test: Group I: 30 patients with HELLP syndromePregnant patients diagnosed with HELLP syndrome enrolled prospectively to evaluate platelet indices and inflammatory markers and their prognostic value on maternal and clinical outcomes. |
| Healthy pregnant controlled group | – | Diagnostic Test: Group I: 30 patients with HELLP syndromeHealthy pregnant women without hypertensive disorders of pregnancy recruited as a control group for comparison. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with HELLP syndrome in surgical intensive care unit
Key inclusion criteria (1 listed)
- Pregnant women aged 18 and 45 years. Gestational age ranged from 28 to 41 weeks. Pregnant women diagnosed with HELLP syndrome. Preeclampsia with Hellp syndrome. Pt with HELLP syndrome was delivered by ceserian section(SC)then admitted to Intensive care unit (ICU) only normal singleton pregnancies without fetal congenital or chromosomal anomalies
Key exclusion criteria (1 listed)
- Patients with infection and fever. Women with a history of diabetes, hypertension, systemic or endocrine disorder, chronic infection, chronic renal disease Liver diseases. Blood diseases. Drugs affecting platelet counts or functions. Any history of membrane rupture
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 |
|---|---|---|
| Group I: 30 patients with HELLP syndromeAll patients will be subjected to the following in ICU through 48 hrs Detailed medical history taking: Demographic data (age, weight, height, body mass index (BMI). Physical examination (conscious level-vital signs) Type of anesthesia (spinal -general anesthesia) Number of pregnancies, parity, history of previous pregnancies, smoking status, and history of assisted reproductive treatments. Laboratory investigations, indices and inflammatory markers: will be obtained after delivery, once the patient is admitted to the intensive care unit. Complete blood counts (CBC). Biochemical analyses [such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), albumin ,bilirubin and creatinine]. The indices include platelet count (PC), MPV, PDW, and plateletcrit (PCT), among these, PDW, an indicator of platelet size heterogeneity, is a marker of platelet function. It is being evaluated as a potential indicator for the risk prediction of | Diagnostic test | HELLP syndrome group, Healthy pregnant controlled group |
Primary outcome
This study aims to evaluate the prognostic values of platelet indices and inflammatory markers in patients with HELLP syndrome
Time frame: 48Hours
To investigate prognostic values of platelet indices and. . inflammatory markers in HELLP syndrome patients as main indices including (NLR-PLR-MPV-PDW and RDW)
1 secondary outcome
Evaluation complications of HELLP syndrome
Time frame: 48 hours
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 30 Jan 2026.
- Individual participant dataSharing planned: No
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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, run by Sohag 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 1 inclusion and 1 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 30 Jan 2026. 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 Esraa Gaheen Ali, Resident (01066768174, esraa-jaheen-post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study aims to evaluate the prognostic values of platelet indices and inflammatory markers in patients with HELLP syndrome (time frame: 48Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026.