Inflammatory Biomarkers for the Diagnosis of oPRES

Inflammatory Biomarkers for the Diagnosis of Obstetric Posterior Reversible Encephalopathy Syndrome

The purpose of this study is to explore the inflammatory biomarkers for the diagnosis of obstetric posterior reversible encephalopathy syndrome.

Study Overview

• Status: Completed
• Conditions: Posterior Reversible Encephalopathy Syndrome; Inflammatory Biomarkers; Neutrophil-lymphocyte Ratio
• Intervention / Treatment: Other: Whether the PE or E patient combined with PRES

Detailed Description

The investigators retrospectively collected data (General information, clinical data, biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman diagnosed with PRES to explore the inflammatory biomarkers for the diagnosis of oPRES during 2012 to 2021.Then, the investigators grouped all the patients into PRES group (PE or E with PRES) and NOT-PRES group (PE or E without PRES) according to the diagnostic criteria of PRES. Then, the investigators analysed the inflammatory biomarkers, such as neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), monocyte-lymphocyte ratio (MLR), and so on of two groups, and compared the difference of tow groups.

• Study Type: Observational
• Enrollment (Actual): 621

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510150
    • Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women diagnosed with PE or E.

Description

Inclusion Criteria:

1. Pregnant women were diagnosed of PE or E.
2. All patients were examined the cranial imaging (MRI or CT), and imaging findings meeting the diagnostic criteria of PRES or normal.
3. all patients provided written informed consent.

Exclusion Criteria:

1. patients combined with other neurological disorders
2. patients combined with mental illness

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRES group; patients in PE or E with PRES	Other: Whether the PE or E patient combined with PRES; According to the Diagnostic criteria of PRES, all the patients grouped into two groups.
NON-PRES group; patients in PE or E without PRES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory biomarkers	The values of neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and monocyte-lymphocyte ratio will be measured.	Inflammatory biomarkers were collected within 1 day after the onset of symptoms.
cranial Imaging	According to the cranial Imaging, PE or E patients were grouped into PRES group (typical features presence of vasogenic edema in the white matter of the portions of both cerebral hemispheres) and NOT-PRES group (imaging findings were normal).	Cranial Imaging was examined within 3 days after the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy outcomes	The rates of stillbirth and premature birth (gestation less than 37 weeks) in PRES patients.	The pregnancy outcomes will record immediately when the patients deliver.
other biochemical parameters	The levels of C-Reactive protein (CRP) will be measured,and CRP﹥8000μg/L means a worse outcome.	biochemical parameters were collected within 1 week of the hospital stay.
Blood Pressure(BP)	blood pressure including systolic blood pressure (SBP), and diastolic blood pressure (DBP).	The BP of patients was obtained within 1hour after the onset of symptoms.

Collaborators and Investigators

• Sponsor: Dunjin Chen
• Investigators: Principal Investigator: Dunjin Chen, The Third Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Disease; Leukoencephalopathies; Hypertensive Encephalopathy; Intracranial Hypertension; Syndrome; Brain Diseases; Posterior Leukoencephalopathy Syndrome
• Other Study ID Numbers: 2019B08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No