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Completed

NCT Number: NCT05143710

The Clinical and Prognostic Features of PRES

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.

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Key information

Conditions

Posterior Reversible Encephalopathy Syndrome Brain Diseases Central Nervous System Diseases Eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Hypertensive Encephalopathy Intracranial Hypertension Leukoencephalopathies Nervous System Diseases Posterior Leukoencephalopathy Syndrome Pre-Eclampsia Preeclampsia Pregnancy Complications Pregnancy Outcomes Urogenital Diseases

Age range

16 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

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

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PRES in PE or E

Diagnostic Test

patients diagnosed with posterior reversible encephalopathy syndrome with preeclampsia or eclampsia

Primary outcomes

  1. features of clinical imaging

    Time frame: 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.

    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.

  2. blood pressure(BP)

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

    hypertension：≥140/90mmHg

  3. biochemical parameters

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

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

  4. pregnancy outcomes

    Time frame: The pregnancy outcomes will record immediately when the patients deliver.

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

  5. pregnancy outcomes

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

    The PRES patients may have longer time of hospitalization.

Sponsors and collaborators

Lead sponsor

Dunjin Chen

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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