CClinicalTrials.gg
Status unknownNCT05140850Updated Dec 8, 2021

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

An observational study in Neuroimaging, Cognitive Dysfunction and Posterior Reversible Encephalopathy Syndrome, sponsored by Dunjin Chen. Status unknown at 1 site in China. Open to female participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-12-08.

Sponsored by Dunjin Chen · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
15 Years to 60 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Neuroimaging
  • Cognitive Dysfunction
  • Posterior Reversible Encephalopathy Syndrome
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In context

Brain Diseases

758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.

This study's planned enrollment of 500 is above the median of 100 across 265 observational studies indexed under Brain Diseases.

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Lead sponsor

Dunjin Chen is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Inclusion criteria

  1. patients were diagnosed of PE or E
  2. patients received cranial image examination
  3. patients consent to participate

Exclusion criteria

Exclusion Criteria:

  1. patients combined other neurological diseases
  2. patients combined mental illness
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Biologicalneuroimaging 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 10 years after deliver

  2. 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).

    Time frame: within 10 years after deliver

  3. neuro-cognitive test of Montreal Cognitive Assessment

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

    Time frame: within 10 years after deliver

  4. blood pressure and hypertension

    Hypertension: blood pressure ≥140/90 mmHg

    Time frame: within 10 years after deliver

  5. level of lactate dehydrogenase(LDH)

    inflammatory: LDH\>380U/L

    Time frame: within 10 years after deliver

  6. level of LDL in blood

    hyperlipidemia:LDL\>3.12mmol/L

    Time frame: within 10 years after deliver

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Study locations

1 site
  • 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
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05140850
Lead sponsor
Dunjin Chen
Responsible party
Dunjin Chen (Director of obstetrics, Guangzhou Medical University) — Sponsor-investigator
First posted
Dec 1, 2021
Start date
Jan 2022 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Oct 2023 (estimated)
Last update
Dec 8, 2021

Study contacts

Dunjin Chen
Contact
gzdrchen@gzhmu.edu.cn
18928916722

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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