Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):

Eclampsia Clinical Trial

— PRESIDEX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02027272
• Other study ID #: 2011-0269
• Status: Terminated
• Phase: N/A
• First received: January 15, 2013
• Last updated: January 2, 2014
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Eclampsia

Intervention

Drug:
• Dexamethasone
Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No