Inflammatory Biomarkers for the Diagnosis of oPRES

NCT05433870 — Completed, 621 participants, Dunjin Chen

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Inflammatory Biomarkers for the Diagnosis of Obstetric Posterior Reversible Encephalopathy Syndrome

Registry	NCT05433870
Status	Completed
Study type	Observational
Enrollment	621 (Actual)
Sponsor	Dunjin Chen (Other)
Conditions	Posterior Reversible Encephalopathy Syndrome, Inflammatory Biomarkers, Neutrophil-lymphocyte Ratio
Interventions	Whether the PE or E patient combined with PRES (Other)
Dates	start 2022-07-01, primary completion 2022-07-31, completion 2022-07-31, first posted 2022-06-27, last updated 2022-08-03
Locations	1 site in China

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
PRES group		Other: Whether the PE or E patient combined with PRES	patients in PE or E with PRES
NON-PRES group			patients in PE or E without PRES

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

+Outcome measures

Primary outcomes

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.
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).

Secondary outcomes

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.

+Eligibility

Sex: Female, ages: 16 Years to 50 Years

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

+Locations (1)

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

+Investigators

Dunjin Chen, Principal investigator, The Third Affiliated Hospital of Guangzhou Medical University