EclampsiaPRESIDEXNCT02027272
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):
A study testing Dexamethasone in people with Eclampsia, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome (PRES) encountered in eclamptic patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Eclampsia
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Currently 34 weeks pregnant or within 6 weeks postpartum
- At least 18 years of age
- Singleton or twin gestation
- Patient or family sign informed consent
- Diagnosis of eclampsia
- Able to obtain MRI scanning within 24hours of hosp admit and/or seizure
Who cannot join
- Neither pregnant nor within first 6 weeks postpartum
- Patient or family unable to sign informed consent
- Less than 18 years of age
- Triplet or higher order gestation
- Unable to obtain MRI scanning within 24 hours of hospital admission (
- Diagnosis of cerebral hemorrhage
- Patient in whom MRI is contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): A Randomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery.
This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo or steroid will receive standard therapy to include magnesium sulfate, blood pressure medications and diuretics. We hypothesize that the addition of dexamethasone to standard therapy will accelerate CNS recovery more quickly than standard management without dexamethasone.
Read the detailed description
30 eclamptic patients who do not require steroids for fetal lung maturation purposes will be randomized to placebo or steroid. This includes patients with eclampsia encountered antepartum prior to 23 weeks gestation, postpartum eclampsia, undelivered patients encountered after 33 weeks gestation who would not be candidates for fetal lung maturation steroids, or patients not eligible for repeat steroid administration in the 23-34 week gestational window. Planned enrollment in this pilot study is up to 30 patients with at least 12 in each group.
- Conditions
- Eclampsia
- Being tested
- Dexamethasone
- Keywords
- Eclampsia
- Medical subject headings
- Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Potent glucocorticoid or steroid
Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Dexamethasone 12 mg, 2 doses, 12 hours apart. Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Placebo, 2 doses, 12 hours apart Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery
To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Difficulty recruiting, only one participant in 18 months, rarity of event
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EclampsiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Martin, University of Mississippi Medical Center
- Investigators
- James Martin, MD, Principal investigator, University of Mississippi Medican Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027272
- Sponsor's protocol ID
- 2011-0269
- Acronym
- PRESIDEX
- Status last verified
- Apr 2016
- First submitted
- 15 Jan 2013
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): A Randomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery.
- ClinicalTrials.gov ID
- NCT02027272
- Acronym / sponsor ID
- PRESIDEX / 2011-0269
- Conditions
- Eclampsia
- Keywords
- Eclampsia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting, only one participant in 18 months, rarity of event
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo or steroid will receive standard therapy to include magnesium sulfate, blood pressure medications and diuretics. We hypothesize that the addition of dexamethasone to standard therapy will accelerate CNS recovery more quickly than standard management without dexamethasone.
Detailed description
30 eclamptic patients who do not require steroids for fetal lung maturation purposes will be randomized to placebo or steroid. This includes patients with eclampsia encountered antepartum prior to 23 weeks gestation, postpartum eclampsia, undelivered patients encountered after 33 weeks gestation who would not be candidates for fetal lung maturation steroids, or patients not eligible for repeat steroid administration in the 23-34 week gestational window. Planned enrollment in this pilot study is up to 30 patients with at least 12 in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneDexamethasone 12 mg, 2 doses, 12 hours apart. |
| Placebo | Placebo comparator | Drug: DexamethasonePlacebo, 2 doses, 12 hours apart |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Currently 34 weeks pregnant or within 6 weeks postpartum
- At least 18 years of age
- Singleton or twin gestation
- Patient or family sign informed consent
- Diagnosis of eclampsia
Key exclusion criteria (7 listed)
- Neither pregnant nor within first 6 weeks postpartum
- Patient or family unable to sign informed consent
- Less than 18 years of age
- Triplet or higher order gestation
- Unable to obtain MRI scanning within 24 hours of hospital admission (
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 |
|---|---|---|
| DexamethasoneAlso: Potent glucocorticoid or steroidIntravenous Dexamethasone 12 mg, 2 doses, 12 hours apart | Drug | Dexamethasone, Placebo |
Primary outcome
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery
Time frame: 36 months
To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James Martin, MD principal investigator
University of Mississippi Medican Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Eclampsia, run by University of Mississippi Medical Center at 1 site in United States.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 May 2016. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery (time frame: 36 months). 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 26 May 2016; AzTrials last refreshed its copy on 27 Oct 2026.