NCT07377786

Brief 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). .

  • 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. .

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Feb 2026

Shorter than P25 for all trials

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 Progress32%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 22, 2026

Last Update Submit

January 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    48Hours

Secondary Outcomes (1)

  • Evaluation complications of HELLP syndrome

    48 hours

Study Arms (2)

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.

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.

Diagnostic Test: Group I: 30 patients with HELLP syndrome

Interventions

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

HELLP syndrome groupHealthy pregnant controlled group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHELlP syndrome in pregnant woman
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with HELLP syndrome in surgical intensive care unit

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HELLP Syndrome

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Esraa Gaheen Ali, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesia,surgical Intensive Care, and Pain Management Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 30, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share