Inflammatory Biomarkers for the Diagnosis of oPRES

NCT05433870 | Completed

• 1 other identifier: 2019B08
• Study Type: observational
• Target: 621
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Posterior Reversible Encephalopathy Syndrome; Inflammatory Biomarkers; Neutrophil-lymphocyte Ratio

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• other biochemical parameters

  biochemical parameters were collected within 1 week of the hospital stay.

• Blood Pressure(BP)

  The BP of patients was obtained within 1hour after the onset of symptoms.

• pregnancy outcomes

  The pregnancy outcomes will record immediately when the patients deliver.

Study Arms (2)

PRES group

patients in PE or E with PRES

Other: Whether the PE or E patient combined with PRES

NON-PRES group

patients in PE or E without PRES

Interventions

Whether the PE or E patient combined with PRES OTHER

According to the Diagnostic criteria of PRES, all the patients grouped into two groups.

PRES group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women diagnosed with PE or E.

You may qualify if:

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

You may not qualify if:

• patients combined with other neurological disorders
• patients combined with mental illness

Sponsors & Collaborators

• Dunjin Chen: lead

Study Sites (1)

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

Guangzhou, 510150, China

Location

MeSH Terms

Conditions

Posterior Leukoencephalopathy Syndrome

Interventions

Pressure

Condition Hierarchy (Ancestors)

Hypertensive Encephalopathy; Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Dunjin Chen

  The Third Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of obstetrics

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 27, 2022
• Study Start: July 1, 2022
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)