Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):

Study Overview
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Brief Summary
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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
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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.

Official Title
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Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): A Randomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery.

Conditions
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Eclampsia

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Dexamethasone 12 mg, 2 doses, 12 hours apart. | Drug: Dexamethasone<br>* Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart<br>* Other names: Potent glucocorticoid or steroid;|
| Placebo Comparator: Placebo<br>Placebo, 2 doses, 12 hours apart | Drug: Dexamethasone<br>* Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart<br>* Other names: Potent glucocorticoid or steroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eclampsia