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Completed

NCT Number: NCT05310513

The Predictors of ICU Admission of oPRES

The purpose of this study is to explore the predictors of ICU admission of obstetric posterior reversible encephalopathy syndrome.

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Key information

Conditions

Posterior Reversible Encephalopathy Syndrome Brain Diseases Central Nervous System Diseases Hypertensive Encephalopathy Intensive Care Units Intracranial Hypertension Leukoencephalopathies Nervous System Diseases Posterior Leukoencephalopathy Syndrome

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 to explore the predictors of ICU admission during 2012 to 2021.Then, the investigators grouped all the patients into ICU group and Non-ICU group according to ICU admission or not.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant Women were diagnosed of PRES.
  • all patients provided written informed consent

Exclusion criteria

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

Treatment and study plan

Whether the patient needs to be admitted to the ICU

Other

According to ICU admission or not, patients were grouped into ICU group and NOT-ICU group.

Primary outcomes

  1. Blood Pressure(BP)

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

    blood pressure including systolic blood pressure (SBP), and diastolic blood pressure (DBP).

  2. severity of the edema

    Time frame: Cranial Imaging was examined immediately at the onset of symptoms, such as s headaches, visual changes, seizures, consciousness impairment.

    The extent and severity of the edema observed in the lesion area were graded on a scale of 0-5 by evaluating FLAIR images.(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 com- pletely confluent; 5, involved regions are fully confluent and con- tinuous, ventricular deformity due to the oedema).

  3. 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.

  4. biochemical parameters

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

    The level of lactate dehydrogenase(LDH) will be measured，and LDH﹥380U/L means a worse outcome.

Sponsors and collaborators

Lead sponsor

Dunjin Chen

Other

Registry information

Official study title

The Predictors of ICU Admission of Obstetric Posterion Reversible Encephalopathy Syndrome

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Jun 14, 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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