The Clinical and Prognostic Features of PRES

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143710
• Other study ID #: 2020M682675
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2022
• Source: Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Eclampsia
• Posterior Reversible Encephalopathy Syndrome
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Outcomes
• Syndrome

Intervention

Diagnostic Test:
• PRES in PE or E
patients diagnosed with posterior reversible encephalopathy syndrome with preeclampsia or eclampsia

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Dunjin Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	blood pressure(BP)	hypertension:=140/90mmHg	The BP of patients was obtained immediately at the onset of symptoms.
Primary	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.
Primary	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.
Primary	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.