Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): (PRESIDEX)

University of Mississippi

Status: Terminated

Conditions: Eclampsia

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02027272

2011-0269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups, including a placebo group

Dexamethasone

Active Comparator group

Description:

Dexamethasone 12 mg, 2 doses, 12 hours apart.

Treatment:

Drug: Dexamethasone

Placebo

Placebo Comparator group

Description:

Placebo, 2 doses, 12 hours apart

Treatment:

Drug: Dexamethasone