Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

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.

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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.

Conditions

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Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexamethasone

Dexamethasone 12 mg, 2 doses, 12 hours apart.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart

Placebo

Placebo, 2 doses, 12 hours apart

Group Type PLACEBO_COMPARATOR

Dexamethasone

Intervention Type DRUG

Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart

Interventions

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Dexamethasone

Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart

Intervention Type DRUG

Other Intervention Names

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Potent glucocorticoid or steroid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No