Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in oPRES

• Conditions: Cognitive Dysfunction; Posterior Reversible Encephalopathy Syndrome; Neuroimaging

• Registration Number: NCT05140850
• Lead Sponsor: Dunjin Chen

Brief Summary

The purpose of this study is to explore the long-term consequences of neuroimaging and perceived cognitive dysfunction in obstetrics posterior reversible encephalopathy syndrome.

Detailed Description

This is a prospective study. The investigators divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . The general information（demographic data，blood pressure.etc.）and blood sample will be collected. Additionally,all patients receive neuroimaging examination（DTI,ASL,3D-TMI.etc.）and neuro-cognitive test（MMSE,MOCA,CFQ, etc.） to assess the cerebral white matter lesions and cognitive changes.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-21
• Study First Posted: 2021-12-01
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-08
• Study Start: 2022-01
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1. patients were diagnosed of PE or E
2. patients received cranial image examination
3. patients consent to participate

Exclusion Criteria

1. patients combined other neurological diseases
2. patients combined mental illness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neuroimaging examination	within 10 years after deliver	the degree of white matter lesions(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 completely confluent; 5, involved regions are fully confluent and continuous, ventricular deformity due to the oedema).The value of fractional anisotropy(FA) in PRES group may higher than non- PRES group, and mean diffusivity (MD) in PRES group may lower than non- PRES group.
neuro-cognitive test of Montreal Cognitive Assessment	within 10 years after deliver	the scores of Montreal Cognitive Assessment,normal (≥26); abnormal (\<26).
level of lactate dehydrogenase(LDH)	within 10 years after deliver	inflammatory: LDH\>380U/L
neuro-cognitive test of Mini-mental State Examination	within 10 years after deliver	the scores of Mini-mental State Examination,normal (27-30);mild (21-26); moderate (10-20); severe (0-9).
blood pressure and hypertension	within 10 years after deliver	Hypertension: blood pressure ≥140/90 mmHg
level of LDL in blood	within 10 years after deliver	hyperlipidemia：LDL\>3.12mmol/L

Trial Locations

Locations (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