Inflammatory Biomarkers for the Diagnosis of oPRES

Completed

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

• Registration Number: NCT05433870
• Lead Sponsor: Dunjin Chen

Brief Summary

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

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 Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-27
• Study Start: 2022-07-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 621

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PRES group	Whether the PE or E patient combined with PRES	patients in PE or E with PRES

Primary Outcome Measures

Name	Time	Method
cranial Imaging	Cranial Imaging was examined within 3 days after the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment.	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).
inflammatory biomarkers	Inflammatory biomarkers were collected within 1 day after the onset of symptoms.	The values of neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and monocyte-lymphocyte ratio will be measured.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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