The Clinical and Prognostic Features of PRES

NCT05143710 | Completed

• 1 other identifier: 2020M682675
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the features of clinical imaging, disease severity and pregnancy outcomes in posterior reversible encephalopathy syndrome with preeclampsia or eclampsia.

Conditions

Posterior Reversible Encephalopathy Syndrome; Pregnancy Outcomes; Preeclampsia; Eclampsia

Outcome Measures

Primary Outcomes (5)

• features of clinical imaging

  The imaging features were described by their location including frontal, parietal, occipital, temporal, cerebellum, basal ganglia, brain stem, deep white matter and callosum, and 1 point was recorded for each location involved.

  Cranial Imaging was examined immediately at the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment, mental disorders, and focal neurological deficits.

• blood pressure(BP)

  hypertension：≥140/90mmHg

  The BP of patients was obtained immediately at the onset of symptoms.

• biochemical parameters

  The PRES patients may have a lower level of serum albumin (﹤35g/L) ,and have a higher level of lactic dehydrogenase (﹥380U/L).

  Biochemical indicators were collected within 1 week of the hospital stay.

• pregnancy outcomes

  The rates of stillbirth and premature birth (gestation less than 37 weeks) in PRES patients.

  The pregnancy outcomes will record immediately when the patients deliver.

• pregnancy outcomes

  The PRES patients may have longer time of hospitalization.

  From day of admission until the day of discharge or date of death from any cause,whichever came first,assessed up to 1 year.

Study Arms (1)

PRES in PE or E

patients diagnosed with PRES in PE or E

Diagnostic Test: PRES in PE or E

Interventions

PRES in PE or E DIAGNOSTIC_TEST

patients diagnosed with posterior reversible encephalopathy syndrome with preeclampsia or eclampsia

PRES in PE or E

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant woman diagnosed with PRES with preeclampsia or eclampsia

You may qualify if:

• patients were diagnosed of PRES with PE or E
• all patients provided written informed consent

You may not qualify if:

• patients combined with other neurological disorders
• patients combined with mental illness

Sponsors & Collaborators

• Dunjin Chen: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Posterior Leukoencephalopathy Syndrome; Pre-Eclampsia; Eclampsia

Interventions

Pressure

Condition Hierarchy (Ancestors)

Hypertensive Encephalopathy; Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of obstetrics

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 3, 2021
• Study Start: October 1, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

CN (1)