Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):

N/ATerminatedNCT02027272

University of Mississippi Medical Center1 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Eclampsia

Interventions

DexamethasoneDRUG

Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Currently 34 weeks pregnant or within 6 weeks postpartum 2. At least 18 years of age 3. Singleton or twin gestation 4. Patient or family sign informed consent 5. Diagnosis of eclampsia 6. Able to obtain MRI scanning within 24hours of hosp admit and/or seizure Exclusion Criteria: 1. Neither pregnant nor within first 6 weeks postpartum 2. Patient or family unable to sign informed consent 3. Less than 18 years of age 4. Triplet or higher order gestation 5. Unable to obtain MRI scanning within 24 hours of hospital admission ( 6. Diagnosis of cerebral hemorrhage 7. Patient in whom MRI is contraindicated

Locations (1)

University of Mississippi Medical Center

Jackson, Mississippi, United States

Outcomes

Primary Outcomes

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.

Time frame: 36 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.