Cognitive Dysfunction Clinical Trial
Official title:
Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in Obstetrics Posterior Reversible Encephalopathy Syndrome
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 |
The purpose of this study is to explore the long-term consequences of neuroimaging and perceived cognitive dysfunction in obstetrics posterior reversible encephalopathy syndrome.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Dunjin Chen |
China,
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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