Posterior Reversible Encephalopathy Syndrome Clinical Trial
Official title:
Inflammatory Biomarkers for the Diagnosis of Obstetric Posterior Reversible Encephalopathy Syndrome
NCT number | NCT05433870 |
Other study ID # | 2019B08 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | July 31, 2022 |
Verified date | June 2022 |
Source | Guangzhou Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to explore the inflammatory biomarkers for the diagnosis of obstetric posterior reversible encephalopathy syndrome.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Dunjin Chen |
China,
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. |
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