The Predictors of ICU Admission of oPRES

NCT05310513 | Completed

• 1 other identifier: 2019A151510102
• Study Type: observational
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Posterior Reversible Encephalopathy Syndrome; Intensive Care Units

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

ICU group

patients admitted to ICU with PRES.

Other: Whether the patient needs to be admitted to the ICU

Non-ICU group

patients not admitted to ICU with PRES.

Other: Whether the patient needs to be admitted to the ICU

Interventions

Whether the patient needs to be admitted to the ICU OTHER

According to ICU admission or not, patients were grouped into ICU group and NOT-ICU group.

ICU group; Non-ICU group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women diagnosed with PRES

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dunjin Chen: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Posterior Leukoencephalopathy Syndrome

Condition Hierarchy (Ancestors)

Hypertensive Encephalopathy; Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies

Study Officials

• Dunjin Chen

  The Third Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of obstetrics

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 5, 2022
• Study Start: April 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)