Eclampsia
Conditions
Keywords
Eclampsia
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.
Interventions
DRUGDexamethasone
Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Dexamethasone 12 mg, 2 doses, 12 hours apart.
Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart | 0 |
| Placebo Placebo, 2 doses, 12 hours apart | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Placebo | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 1 participants | 1 participants |
| Gender Female | 1 participants | 1 participants |
| Gender Male | 0 participants | 0 participants |
| Region of Enrollment United States | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 36 months
Population: Logistic hurdles caused to stop the study after the first participant and not proceed further. No analysis was undertaken.