Inflammatory Biomarkers for the Diagnosis of oPRES

Sponsor
Dunjin Chen (Other)
Overall Status
Completed
CT.gov ID
NCT05433870
Collaborator
(none)
621
1
30
630.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Whether the PE or E patient combined with PRES

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 Design

Study Type:
Observational
Actual Enrollment :
621 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Inflammatory Biomarkers for the Diagnosis of Obstetric Posterior Reversible Encephalopathy Syndrome
Actual Study Start Date :
Jul 1, 2022
Actual Primary Completion Date :
Jul 31, 2022
Actual Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
PRES group

patients in PE or E with PRES

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

NON-PRES group

patients in PE or E without PRES

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 Outcome Measures

  1. 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.

  2. 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).

  3. 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 Criteria

Criteria

Ages Eligible for Study:
16 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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 510150

Sponsors and Collaborators

  • Dunjin Chen

Investigators

  • Principal Investigator: Dunjin Chen, The Third Affiliated Hospital of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dunjin Chen, Director of obstetrics, Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT05433870
Other Study ID Numbers:
  • 2019B08
First Posted:
Jun 27, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022