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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05140850
Other study ID # 82001568
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2022
Est. completion date October 2023

Study information

Verified date November 2021
Source Guangzhou Medical University
Contact Dunjin Chen
Phone 18928916722
Email gzdrchen@gzhmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
neuroimaging examination,neuro-cognitive test,blood pressure,blood sample
neuroimaging will be perform,neuro-cognitive will be tested,blood pressure will be monitored,blood samples will be tested

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 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 con?uent; 5, involved regions are fully con?uent 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
Primary 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
Primary neuro-cognitive test of Montreal Cognitive Assessment the scores of Montreal Cognitive Assessment,normal (=26); abnormal (<26). within 10 years after deliver
Primary blood pressure and hypertension Hypertension: blood pressure =140/90 mmHg within 10 years after deliver
Primary level of lactate dehydrogenase(LDH) inflammatory: LDH>380U/L within 10 years after deliver
Primary level of LDL in blood hyperlipidemia:LDL>3.12mmol/L within 10 years after deliver
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