Posterior Reversible Encephalopathy SyndromeNCT05143710
The Clinical and Prognostic Features of PRES
An observational study of Posterior Reversible Encephalopathy Syndrome and Pregnancy Outcomes, run by Dunjin Chen at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Posterior Reversible Encephalopathy Syndrome, Pregnancy Outcomes, Preeclampsia
- What is being tested?
- PRES in PE or E
- How many people
- 354 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: pregnant woman diagnosed with PRES with preeclampsia or eclampsia
Who may be able to join
- patients were diagnosed of PRES with PE or E
- all patients provided written informed consent
Who cannot join
- patients combined with other neurological disorders
- patients combined with mental illness
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510150
About this study
Official title: 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.
Read the 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 .
- Being tested
- PRES in PE or E
- Medical subject headings
- Posterior Leukoencephalopathy Syndrome, Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRES in PE or EDiagnostic test
patients diagnosed with posterior reversible encephalopathy syndrome with preeclampsia or eclampsia
| Study group | Role | What they receive |
|---|---|---|
| PRES in PE or E | patients diagnosed with PRES in PE or E Receives: Diagnostic Test: PRES in PE or E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: The pregnancy outcomes will record immediately when the patients deliver.
pregnancy outcomes
The PRES patients may have longer time of hospitalization.
Measured: From day of admission until the day of discharge or date of death from any cause,whichever came first,assessed up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Oct 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Reversible Encephalopathy SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dunjin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dunjin Chen, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143710
- Sponsor's protocol ID
- 2020M682675
- Status last verified
- Feb 2022
- First submitted
- 10 Nov 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Features of Clinical Imaging, Disease Severity and Pregnancy Outcomes in Posterior Reversible Encephalopathy Syndrome With Preeclampsia or Eclampsia
- ClinicalTrials.gov ID
- NCT05143710
- Acronym / sponsor ID
- 2020M682675
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Dunjin ChenUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRES in PE or E | – | Diagnostic Test: PRES in PE or Epatients diagnosed with PRES in PE or E |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pregnant woman diagnosed with PRES with preeclampsia or eclampsia
Key inclusion criteria (2 listed)
- patients were diagnosed of PRES with PE or E
- all patients provided written informed consent
Key exclusion criteria (2 listed)
- patients combined with other neurological disorders
- patients combined with mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRES in PE or Epatients diagnosed with posterior reversible encephalopathy syndrome with preeclampsia or eclampsia | Diagnostic test | PRES in PE or E |
Primary outcome
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.
blood pressure(BP)
Time frame: The BP of patients was obtained immediately at the onset of symptoms.
hypertension：≥140/90mmHg
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Related trials for Posterior Reversible Encephalopathy Syndrome
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Posterior Reversible Encephalopathy Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Reversible Encephalopathy Syndrome and Pregnancy Outcomes, run by Dunjin Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.