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

Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in Obstetrics Posterior Reversible Encephalopathy Syndrome

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Dysfunction; Neuroimaging; Posterior Reversible Encephalopathy Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510150
    • Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dunjin Chen

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Disease; Cognition Disorders; Leukoencephalopathies; Hypertensive Encephalopathy; Intracranial Hypertension; Syndrome; Cognitive Dysfunction; Brain Diseases; Posterior Leukoencephalopathy Syndrome
• Other Study ID Numbers: 82001568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No