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Completed

NCT Number: NCT05433870

Inflammatory Biomarkers for the Diagnosis of oPRES

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

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Key information

Conditions

Posterior Reversible Encephalopathy Syndrome Brain Diseases Central Nervous System Diseases Hypertensive Encephalopathy Inflammatory Biomarkers Intracranial Hypertension Leukoencephalopathies Nervous System Diseases Neutrophil-Lymphocyte Ratio Posterior Leukoencephalopathy Syndrome

Age range

16 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Whether the PE or E patient combined with PRES

Other

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

Primary outcomes

  1. inflammatory biomarkers

    Time frame: 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.

  2. cranial Imaging

    Time frame: 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

  1. other biochemical parameters

    Time frame: 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.

  2. Blood Pressure(BP)

    Time frame: 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).

  3. pregnancy outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dunjin Chen

Other

Registry information

Official study title

Inflammatory Biomarkers for the Diagnosis of Obstetric Posterior Reversible Encephalopathy Syndrome

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2022
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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