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

NCT05140850 | Unknown

• 1 other identifier: 82001568
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroimaging; Cognitive Dysfunction; Posterior Reversible Encephalopathy Syndrome

Outcome Measures

Primary Outcomes (6)

• neuroimaging examination

  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.

  within 10 years after deliver

• neuro-cognitive test of Mini-mental State Examination

  the scores of Mini-mental State Examination,normal (27-30);mild (21-26); moderate (10-20); severe (0-9).

  within 10 years after deliver

• neuro-cognitive test of Montreal Cognitive Assessment

  the scores of Montreal Cognitive Assessment,normal (≥26); abnormal (\<26).

  within 10 years after deliver

• blood pressure and hypertension

  Hypertension: blood pressure ≥140/90 mmHg

  within 10 years after deliver

• level of lactate dehydrogenase(LDH)

  inflammatory: LDH\>380U/L

  within 10 years after deliver

• level of LDL in blood

  hyperlipidemia：LDL\>3.12mmol/L

  within 10 years after deliver

Study Arms (2)

PRES group

PE or E with PRES

Biological: neuroimaging examination,neuro-cognitive test,blood pressure,blood sample

non-PRES group

PE or E without PRES

Biological: neuroimaging examination,neuro-cognitive test,blood pressure,blood sample

Interventions

neuroimaging examination,neuro-cognitive test,blood pressure,blood sample BIOLOGICAL

neuroimaging will be perform,neuro-cognitive will be tested,blood pressure will be monitored,blood samples will be tested

PRES group; non-PRES group

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We 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.

You may qualify if:

• patients were diagnosed of PE or E
• patients received cranial image examination
• patients consent to participate

You may not qualify if:

• patients combined other neurological diseases
• patients combined 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Cognitive Dysfunction; Posterior Leukoencephalopathy Syndrome

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Hypertensive Encephalopathy; Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies

Central Study Contacts

Dunjin Chen

CONTACT

18928916722; gzdrchen@gzhmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of obstetrics

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 1, 2021
• Study Start: January 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)