An interventional study of Dexamethasone in Eclampsia, sponsored by University of Mississippi Medical Center. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-05-26.
Sponsored by University of Mississippi Medical Center · Not applicable, Interventional, and Treatment
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.
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.
758 studies on the registry are indexed under Brain Diseases; 202 are open to participants now.
This study's enrollment of 1 is below the median of 58 across 454 interventional studies indexed under Brain Diseases.
Browse Brain Diseases studies →University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Exclusion Criteria:
Dexamethasone 12 mg, 2 doses, 12 hours apart.
Drug: Dexamethasone
Placebo, 2 doses, 12 hours apart
Drug: Dexamethasone
Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
Also known as: Potent glucocorticoid or steroid
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
| Milestone | Dexamethasone | Placebo |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 0 |
| Not completed | 0 | 1 |
To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.
No measurements were reported for this outcome.
Collected over No AE.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone | — | — | — |
| Placebo | — | — | — |
| Age, Categorical(participants) | Dexamethasone | Placebo | Total |
|---|---|---|---|
| <=18 years | — | 0 | 0 |
| Between 18 and 65 years | — | 1 | 1 |
| >=65 years | — | 0 | 0 |
| Gender(participants) | Dexamethasone | Placebo | Total |
|---|---|---|---|
| Female | — | 1 | 1 |
| Male | — | 0 | 0 |
| Region of Enrollment(participants) | Dexamethasone | Placebo | Total |
|---|---|---|---|
| United States | — | 1 | 1 |
This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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University of Mississippi Medical Center