Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):

NCT02027272 | Terminated Results

• 1 other identifier: 2011-0269
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Eclampsia

Keywords

Eclampsia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 12 mg, 2 doses, 12 hours apart.

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Placebo, 2 doses, 12 hours apart

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart

Also known as: Potent glucocorticoid or steroid

Dexamethasone; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Eclampsia

Interventions

Dexamethasone; Steroids

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: James N. Martin, Jr.
• Organization: University of Mississippi Medical Center

jnmartin@umc.edu

601-984-5358

Study Officials

• James Martin, MD

  University of Mississippi Medican Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 6, 2014
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

US (1)