Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):

Not Applicable

Terminated

• Conditions: Eclampsia
• Interventions: Drug: Dexamethasone

• Registration Number: NCT02027272
• Lead Sponsor: University of Mississippi Medical Center

Brief 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. 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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-01-15
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-06
• Status Verified: 2016-04
• Results First Submitted: 2016-04-19
• Results First Submitted QC: 2016-04-19
• Last Update Submitted: 2016-04-19
• Results First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	Dexamethasone 12 mg, 2 doses, 12 hours apart.
Placebo	Dexamethasone	Placebo, 2 doses, 12 hours apart

Primary Outcome Measures

Name	Time	Method
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery	36 months	To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States