The Clinical and Prognostic Features of PRES

The Features of Clinical Imaging, Disease Severity and Pregnancy Outcomes in Posterior Reversible Encephalopathy Syndrome With Preeclampsia or Eclampsia

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.

Study Overview

• Status: Completed
• Conditions: Eclampsia; Preeclampsia; Pregnancy Outcomes; Posterior Reversible Encephalopathy Syndrome
• Intervention / Treatment: Diagnostic test: PRES in PE or E

Detailed Description

The investigators retrospectively collected data (General information, clinical data, biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman diagnosed with PRES with preeclampsia or eclampsia to analyze features of clinical imaging, disease severity and pregnancy outcomes during 2012 to 2021.Then, the investigators grouped all the patients into early onset group and late onset PE group according to gestational weeks to analyze differences of clinical imaging. Finally, the investigators grouped all the patients into good pregnancy outcomes group and poor pregnancy outcomes group according to diagnostic criteria, including the incidence of stillbirth and premature birth, to analyze differences of clinical imaging .

• Study Type: Observational
• Enrollment (Actual): 354

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: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant woman diagnosed with PRES with preeclampsia or eclampsia

Description

Inclusion Criteria:

1. patients were diagnosed of PRES with PE or E
2. all patients provided written informed consent

Exclusion Criteria:

1. patients combined with other neurological disorders
2. patients combined with mental illness

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRES in PE or E; patients diagnosed with PRES in PE or E	Diagnostic test: PRES in PE or E; patients diagnosed with posterior reversible encephalopathy syndrome with preeclampsia or eclampsia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 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.

Collaborators and Investigators

• Sponsor: Dunjin Chen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Disease; Pregnancy Complications; Hypertension, Pregnancy-Induced; Leukoencephalopathies; Hypertensive Encephalopathy; Intracranial Hypertension; Syndrome; Brain Diseases; Eclampsia; Pre-Eclampsia; Posterior Leukoencephalopathy Syndrome
• Other Study ID Numbers: 2020M682675

Drug and device information, study documents

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