The Predictors of ICU Admission of oPRES

The Predictors of ICU Admission of Obstetric Posterion Reversible Encephalopathy Syndrome

The purpose of this study is to explore the predictors of ICU admission of obstetric posterior reversible encephalopathy syndrome.

Study Overview

• Status: Completed
• Conditions: Intensive Care Units; Posterior Reversible Encephalopathy Syndrome
• Intervention / Treatment: Other: Whether the patient needs to be admitted to the ICU

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 predictors of ICU admission during 2012 to 2021.Then, the investigators grouped all the patients into ICU group and Non-ICU group according to ICU admission or not.

• Study Type: Observational
• Enrollment (Actual): 366

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510150
    • Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women diagnosed with PRES

Description

Inclusion Criteria:

1. Pregnant Women were diagnosed of PRES.
2. all patients provided written informed consent

Exclusion Criteria:

1. patients combined with other neurological disorders
2. patients combined with mental illness

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU group; patients admitted to ICU with PRES.	Other: Whether the patient needs to be admitted to the ICU; According to ICU admission or not, patients were grouped into ICU group and NOT-ICU group.
Non-ICU group; patients not admitted to ICU with PRES.	Other: Whether the patient needs to be admitted to the ICU; According to ICU admission or not, patients were grouped into ICU group and NOT-ICU group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure(BP)	blood pressure including systolic blood pressure (SBP), and diastolic blood pressure (DBP).	The BP of patients was obtained immediately at the onset of symptoms.
severity of the edema	The extent and severity of the edema observed in the lesion area were graded on a scale of 0-5 by evaluating FLAIR images.(0, normal; 1, limited cortical or subcortical white matter oedema; 2, white matter oedema > cortical oedema, white matter oedema extending into deep white matter; 3, white matter oedema > cortex oedema, oedema extending to the ventricular surface; 4, the involved regions substantially extend to the ventricular surface and are almost com- pletely confluent; 5, involved regions are fully confluent and con- tinuous, ventricular deformity due to the oedema).	Cranial Imaging was examined immediately at the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment.
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.
biochemical parameters	The level of lactate dehydrogenase(LDH) will be measured，and LDH﹥380U/L means a worse outcome.	Biochemical indicators were collected within 1 week of the hospital stay.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Disease; Leukoencephalopathies; Hypertensive Encephalopathy; Intracranial Hypertension; Syndrome; Brain Diseases; Posterior Leukoencephalopathy Syndrome
• Other Study ID Numbers: 2019A151510102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No