The Predictors of ICU Admission of oPRES

• Sponsor: Dunjin Chen (Other)
• Overall Status: Completed
• CT.gov ID: NCT05310513
• Collaborator: (none)
• Enrollment: 366
• Location: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 185.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Posterior Reversible Encephalopathy Syndrome; Intensive Care Units	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 Design

• Study Type: Observational
• Actual Enrollment: 366 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: The Predictors of ICU Admission of Obstetric Posterion Reversible Encephalopathy Syndrome
• Actual Study Start Date: Apr 1, 2022
• Actual Primary Completion Date: May 31, 2022
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Blood Pressure(BP) [The BP of patients was obtained immediately at the onset of symptoms.]

   blood pressure including systolic blood pressure (SBP), and diastolic blood pressure (DBP).

2. severity of the edema [Cranial Imaging was examined immediately at the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment.]

   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).

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.

4. biochemical parameters [Biochemical indicators were collected within 1 week of the hospital stay.]

   The level of lactate dehydrogenase(LDH) will be measured，and LDH﹥380U/L means a worse outcome.

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 PRES.

2. 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: NCT05310513
• Other Study ID Numbers: 2019A151510102
• First Posted: Apr 5, 2022
• Last Update Posted: Jun 14, 2022
• Last Verified: Mar 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: Brain Diseases; Posterior Leukoencephalopathy Syndrome; Syndrome

Study Results

No Results Posted as of Jun 14, 2022