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

Sponsor
Dunjin Chen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05140850
Collaborator
(none)
500
1
21
23.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: neuroimaging examination,neuro-cognitive test,blood pressure,blood sample

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in Obstetrics Posterior Reversible Encephalopathy Syndrome
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
PRES group

PE or E with PRES

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

non-PRES group

PE or E without PRES

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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).

  3. neuro-cognitive test of Montreal Cognitive Assessment [within 10 years after deliver]

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

  4. blood pressure and hypertension [within 10 years after deliver]

    Hypertension: blood pressure ≥140/90 mmHg

  5. level of lactate dehydrogenase(LDH) [within 10 years after deliver]

    inflammatory: LDH>380U/L

  6. level of LDL in blood [within 10 years after deliver]

    hyperlipidemia:LDL>3.12mmol/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

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

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dunjin Chen, Director of obstetrics, Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT05140850
Other Study ID Numbers:
  • 82001568
First Posted:
Dec 1, 2021
Last Update Posted:
Dec 8, 2021
Last Verified:
Nov 1, 2021
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:

Study Results

No Results Posted as of Dec 8, 2021