The Predictors of ICU Admission of oPRES

Intensive Care Units Clinical Trial

Official title:

The Predictors of ICU Admission of Obstetric Posterion Reversible Encephalopathy Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310513
• Other study ID #: 2019A151510102
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2022
• Source: Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Intensive Care Units
• Posterior Reversible Encephalopathy Syndrome
• Syndrome

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dunjin Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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 con?uent; 5, involved regions are fully con?uent 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.
Primary	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.
Primary	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.