Inflammatory Biomarkers for the Diagnosis of oPRES

Posterior Reversible Encephalopathy Syndrome Clinical Trial

Official title:

Inflammatory Biomarkers for the Diagnosis of Obstetric Posterior Reversible Encephalopathy Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05433870
• Other study ID #: 2019B08
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: June 2022
• Source: Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Inflammatory Biomarkers
• Neutrophil-lymphocyte Ratio
• Posterior Reversible Encephalopathy Syndrome
• Syndrome

Intervention

Other:
• Whether the PE or E patient combined with PRES
According to the Diagnostic criteria of PRES, all the patients grouped into two groups.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dunjin Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.